Camargo 505(b)(2) Blog

Abuse Deterrence Labeling – Generic vs 505(b)(2) Drug Development

Abuse Deterrence Labeling – Generic vs 505(b)(2) Drug Development With the ongoing opioid epidemic, drug abuse, diversion, and misuse are significant concerns for the FDA. The current opioid abuse problems also present significant opportunities for companies willing to explore new formulation technologies to deter abuse. Camargo has significant experience in opioid abuse and abuse-deterrent labeling. […]
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Protein Product 505(b)(2)s Face a Looming Application “Dead Zone”

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was enacted on March 23, 2010 as part of the Patient Protection and Affordable Care Act (Public Law 111-148). The BPCIA changed the regulation of certain protein products by amending the definition of a “biological product” to include a “protein (except any chemically synthesized polypeptide)”, […]
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The Prodrug Benefit of Utilizing the 505(b)(2) Pathway

Designing a new drug from scratch is costly and time-consuming. One attractive option to differentiate from currently marketed products is to chemically modify the characteristics of an existing drug to create a prodrug. Often a prodrug can improve the safety and efficacy of an approved therapeutic. Here, we discuss the basics of prodrugs, how the […]
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The New FDA Draft Guidance on Chewables

An idea for a more convenient dosage form for an existing drug product often presents an opportunity for a commercial advantage. Fortuitously, it also presents the possibility for using the 505(b)(2) regulatory pathway to product approval, which is often faster and less expensive than the 505(b)(1) route. Recently, FDA issued a brief draft guidance describing […]
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The GRAS Is Not Always Greener

The GRAS Is Not Always Greener: Why GRAS Status Does Not Guarantee Excipient Safety Many, if not most, 505(b)(2) submissions represent a change to an approved drug, usually involving a formulation change. Understandably, the focus of sponsors is often primarily on supporting the safety and efficacy of the active ingredient(s). However, the safety of the […]
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Back to Basics: 505(b)(2) FAQs Part 3: Regulatory Strategies

As the 505(b)(2) expert, Camargo is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Given the growing popularity of the 505(b)(2) pathway for approval of repurposed, reformulated, or unapproved-marketed products, we thought it would be worth providing a refresher. Here is Part […]
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Key Inflection Point in a Drug’s Time to Market: Choice of Regulatory Pathway

Traditional drug development follows a standard process beginning with nonclinical studies and moving into clinical studies, all with the purpose of proving a new drug candidate is safe and effective. When the U.S. opened up an alternate path, 505(b)(2), the primary purpose was to utilize existing data and knowledge, minimize costly animal and human studies, […]
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Back to Basics: 505(b)(2) FAQs Part 2: Clinical and Nonclinical Studies

As the 505(b)(2) expert, Camargo is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Given the growing popularity of the 505(b)(2) pathway for approval of repurposed, reformulated, or unapproved-marketed products, we thought it would be worth providing a refresher. Here is Part […]
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Drug Repositioning: Bringing New Life to Shelved Assets and Existing Drugs

Drug repositioning, also known as drug reprofiling or repurposing, has become an increasingly important part of the drug development process. This book examines the business, technical, scientific, and operational challenges and opportunities that drug repositioning offers. Readers will learn how to perform the latest experimental and computational methods that support drug repositioning, and detailed case […]
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Back to Basics: 505(b)(2) FAQs Part 1

As the 505(b)(2) expert, Camargo is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Given the growing popularity of the 505(b)(2) pathway for approval of repurposed, reformulated, or unapproved marketed products, we thought it would be worth providing a refresher. Here are […]
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The Regulation of Follow-On Biological Products via 505(b)(2)

Strike While the Iron is Hot In December 2015, the U.S. FDA granted approval for Eli Lilly and Company’s Basaglar (insulin glargine injection), a long-acting human insulin product indicated for glycemic control in patients with diabetes mellitus. Basaglar marked the first “follow-on” insulin therapy to be approved in the U.S. through a truncated review pathway […]
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Statistical Bootstrapping Method To Take the Uncertainty out of Drug Development

Statistical Bootstrapping Method Using a Bias-Corrected Acceleration Approach Well-reasoned and properly conducted statistical analyses can be essential to successful drug development, particularly in the context of manufacturing scale-up, process and component changes, and in comparisons with a reference product. Similarity tests between dissolution profiles steer the development path forward based on the quality and interpretation […]
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Fixed-Combination Drug Products: Are Phase 2 and 3 Studies Really Necessary?

Many fixed-dose drug-drug combination products arise from an observation that a synergistic effect occurs when two drugs are administered together, or that both drugs are frequently taken together for convenience. As one or both drugs are typically already approved, the 505(b)(2) pathway is the obvious choice for approval of many drug-drug combination products. We have […]
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Faster Approval of Combination Drug Products Via the 505(b)(2) Pathway

On April 11 and 12, 2016, Ken Phelps, President and CEO of Camargo Pharmaceutical Services, spoke at the 505(b)(2) Forum and CTrials Conference in Tel Aviv, Israel, on the topic of 505(b)(2) Combination Drug Products. What is attractive about the 505(b)(2) regulatory pathway, and specifically, why is it so beneficial for approval of combination products? […]
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Product Ideation: Identifying Your Optimal Drug Development Candidate

It’s a familiar story: Pharmaceutical Company X spends years developing Product Y only to discover at a crucial point in the process that Product Y will not succeed. The result is often millions of dollars and development years wasted. But could drug development failure be prevented? Oftentimes, drug development failure can be attributed to misalignment […]
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Pediatric Applicability or Not–This Revised Guidance Is for You

Since 1994, the statutory and regulatory requirements for drug product labeling for pediatric populations have been evolving. The FDA Modernization Act of 1997 (FDAMA) contained incentives for conducting pediatric studies on drugs that had exclusivity or patent protection. In 2003, the Pediatric Research Equity Act (PREA) was signed into law requiring, for certain drugs, sponsors […]
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Is a Reference Listed Drug Mandatory in the 505(b)(2) Pathway?

If you are a frequent reader of our blog, you know that the 505(b)(2) pathway can facilitate a cheaper, faster drug approval route. This is accomplished by relying on: 1) safety and efficacy data from published literature and/or 2) the agency’s assessment of safety and efficacy of a FDA-approved product, known as the “reference listed […]
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Additional 505(b)(2) Benefits: Selective Safety Data Collection

  Last month CDER/CBER released a short, final guidance, “Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations.” (CDER/CBER, 2016) While brief, the guidance could provide a significant reduction in safety data collection for NDA sponsors. This could be especially true for sponsors using the 505(b)(2) regulatory pathway. […]
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How Much Is a First Cycle Review ANDA Approval Worth to You?

At the recent GPhA meeting in Orlando, Florida, Dr. Kathleen Uhl from the FDA Office of Generic Drugs (OGD) spoke about the quality of Abbreviated New Drug Application (ANDA) submissions and highlighted the detriments of a poor quality submission. All would agree that a poor quality submission is costly for drug product development. Dr. Uhl […]
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Return on Investment for 505(b)(2) Products: Is an “AB” Rating Possible?

Return on Investment for 505(b)(2) Products: Is an “AB” Rating Possible? As new generic product options become more scarce and the competition more fierce, generic manufacturers have recently become very interested in the 505(b)(2) regulatory pathway. The benefits of the 505(b)(2) pathway are well known, such as a potentially lower cost and accelerated path to […]
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2015 505(b)(2) NDA Approvals

2015 was a big year for FDA, with 45 novel new therapies approved — much higher than 28, the average number approved in the past decade. Of the 45 approved in 2015, how many were approved through the 505(b)(2) pathway? And how does the number of approvals through 505(b)(2) compare with previous years? The results […]
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3-Year Exclusivity May Not Be Worth as Much as You Think

It is a widely held tenet that market exclusivity is essential for the successful launch of a new drug. But is this always the case? For products approved through the FDA 505(b)(2) pathway, is pursuing the 3-year period of exclusivity available through Hatch-Waxman always necessary? Or is it possible that a product may succeed without […]
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Drug Development Question? Here’s how to communicate with the FDA!

Earlier this month FDA (CDER and CBER) issued a new draft guidance, Best Practices for Communication Between IND Sponsors and FDA During Drug Development. Based on Camargo’s frequent communications with the Agency during product development, the guidance does not present any profound or significant changes in how they conduct and or prefer communicating with IND […]
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New Nonclinical Guidance for 505(b)(2) Products: No Cause for Alarm

On October 15, 2015, the United States Food and Drug Administration (FDA) issued a new guidance for industry and review staff with more uniform recommendations for the nonclinical safety evaluation of approved drug substances that are reformulated or in which a new route of administration is proposed for a previously approved drug product. These products, […]
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The Winding Path to Derisking Formulation Changes

Originally posted by AAPS Blog 10/7/15 If you are a researcher involved in drug development, you are familiar with the inevitability of change and the need to manage and understand it throughout the development process. No question, it is the status quo, and it must be planned for and managed. As researchers, we know where […]
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Encounters of the Third Sector

As I walked the floor at the International Generic Pharmaceutical Alliance (IGPA) conference in Toronto, I couldn’t help but feel a little gratified. Companies that were once disavowing the 505(b)(2) approval pathway are now driving the conversation. Investors that once shied away from 505(b)(2) products due to their unknown reputations despite the relatively low risks […]
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Enforcement Activities: FDA removes unapproved prescription ear drops

For years FDA has threatened to remove unapproved products (so-called DESI products) from the marketplace. Recently, the FDA took enforcement action against  several unapproved prescription ear drops.  What products will be next?  DESI producers can use the 505(b)(2) pathway to avoid such actions on their products. Let’s take a look at the recent action and show an example of  […]
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Examining the Amarin VASCEPA Saga

The headlines and newscasts reported Amarin’s success in wining off-label promotion, but behind the scenes, another noteworthy action took place – in a very rare action, the FDA rescinded a special protocol assessment (SPA) that would have enabled Amarin to promote the new indication. In this post, we’ll examine the reasons for FDA’s action and […]
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Quality Metrics – Coming Soon to Your Manufacturing Facility

In the July 28th, Federal Register, (Under “Meetings”) FDA announced the availability of the draft guidance “Request for Quality Metrics-Guidance for Industry.” Although there are “requests” for quality metrics in the guidance, the bulk of the document tells industry what quality metrics they will be reporting, at least initially. FDA primarily cites Sections 706 and […]
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Use of Extrusion-Enabled Pharmaceutical Processes in Drug Development via a Streamlined Regulatory Pathway

Extrusion-enabled pharmaceutical processing (E2P2) has long been employed in pharmaceutical development (Drug Development and Industrial Pharmacy. 33:909-926,1043-1057 (2007)). Reasons for utilizing E2P2 include: Enhancing physico-chemical properties of APIs such as solubility and stability Modifying in vivo release of a drug to enhance bioavailability and clinical efficacy Facilitating development and manufacture of fixed combination drug products […]
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Active Ingredients vs. Active Moieties – Perplexity of Understanding the Relationship or Distinction

Recently a federal district court spotlighted FDA’s apparently inconsistent definitions of what constitutes an “active ingredient (AI)”  in rejecting the Agency’s rationale for denying Amarin Pharmaceuticals Inc.’s fish oil capsule Vascepa (icosapent ethyl) (NDA 202057 approved July 26, 2012), request for 5 years of market exclusivity as a New Chemical Entity (NCE).  On Feb. 21, […]
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To List or Not to List – That is the Question

A 505(b)(2) may rely on the FDA’s previous findings of safety and efficacy  of an approved drug product. It is possible to rely on more than one approved drug product.  It is also possible that a 505(b)(2) applicant does not have to rely on any approved drug. The correct choice of listed drug product may allow  […]
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Pediatrics – What are the appropriate age ranges?

As we have noted in this blog previously, under the Pediatric Research Equity Act (PREA), all new drug applications for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication(s) […]
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Priority Review Vouchers are a Big Carrot for Hungry Companies

Priority review vouchers (PRVs), which are fast-becoming a powerful incentive for drug companies, were originally based on a publication (Ridley et al. 2006) from a group at Fuqua School of Business at Duke University in NC. The idea behind PRVs was that developers of treatments for neglected infectious diseases (and later, rare pediatric diseases) would […]
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PhRMA and GPhA team up (!) to offer their EAR proposal to solve generic safety labeling issue

FDA held a public hearing this past Friday (27March2015) to air their proposal that generic companies be responsible for updating their labeling whenever ‘new safety information’* is available. Generic companies argue against such a proposal because it would lead to confusion about safety warnings if every multisource product has different labeling (coincidentally, and privately,  they […]
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Opportunities in Orphan Drug Development for Investors, Pharma and CROs

Orphan drugs, defined in the Orphan Drug Act as drugs developed to treat rare diseases that affect fewer than 200,000 people in the U.S., have begun to make their mark for patients and drug companies. As the number of orphan drugs has increased over the past 30 years, many patients with rare diseases have benefited […]
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REMS/ETASU and Safe Use in Bioequivalence trials

We’ve previously commented regarding the predilection of RLD holders whose product approvals include a Risk Evaluation and Mitigation Strategy (REMS) and Elements To Assure Safe Use (ETASU) to use the REMS/ETASU as a barrier to entry for generic completion.  Specifically, the RLD holder will refuse to sell their product to the prospective generic manufacturers, who […]
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MAPPing out the timing of a Complete Response submission

A type of FDA document which sometimes slides past under the radar is  MAPP, that is, Manual of Policies and Procedures.  These are actually internal FDA documents which are generally analogous to the SOPs FDA requires that industry have and follow.  However, by virtue of the various requirements for transparency placed on FDA, they are […]
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Extending Exclusivity: How Long Will It Really Last?

Last week at the Generic Pharmaceutical Association (GPhA) Annual Meeting, the 21st Century Cures Act, a proposed bill with bipartisan support, was a topic of discussion. Specifically, subtitle L—Dormant Therapies, which would offer 15 years of exclusivity for drugs and biologics approved as dormant therapies. From the House Committee on Energy and Commerce’s bill summary/discussion […]
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2014 505(b)(2) NDA Approvals

2014 drug approvals seem to have rebounded somewhat from the past year. In his annual CDER New Drug Review Update, FDA’s John Jenkins cited 35 NME NDA and BLA approvals (calculated through December 3, 2014), up from 27 in 2013 (see chart below). These approvals include 505(b)(1) NDAs as well as BLAs . Some interesting stats […]
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Manufacturing Support for “Breakthrough Therapy” Designation for Solid Oral Dosage Forms

In November, this author participated in an open forum at the AAPS Annual Meeting focused on streamlining manufacturing and scale up to support ‘breakthrough therapy’ designation for solid oral dosage forms. The goal was to provide clarity for breakthrough therapies and chemistry, manufacturing and controls (CMC) challenges to develop a quality submission in a shortened timeframe where […]
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Therapeutic Equivalence Ratings Under 505(b)(2)

The FDA listing of therapeutic equivalence (TE) ratings can be a murky area for products approved under 505(b)(2) applications. The concept of TE ratings emerged from FDA regulations for generics and revolve around the announcement that the FDA would publish a current listing of all of its approved drugs together with TE ratings. This was […]
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Orphan Drug Exclusivity for a Previously Approved Drug: a 505(b)(2) Conundrum

Until now, if a Sponsor intended to request orphan designation with 7 years of marketing exclusivity for a drug that has already been granted orphan designation, FDA has followed the Code of Federal Regulations (CFR), including the condition described in 21CFR §316.34(c): “If a drug is otherwise the same drug as a previously approved drug […]
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5-Year Exclusivity for Certain Fixed-Combination Drugs with an NCE

The FDA recently posted new Guidance on its website awarding certain fixed-combination drug products (fixed-combinations) 5-year new chemical entity (NCE) exclusivity. While the Agency held previously that these products were ineligible for NCE exclusivity (5 years) if one component is already approved, with this new Guidance in effect, a drug product will be eligible for […]
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Alkermes Prodrug for Treatment of Multiple Sclerosis: NCE?

The Food and Drug Administration (FDA) began requiring drug efficacy, in addition to safety, for approval in 1962 based on the Kefauver-Harris Amendment. Despite this requirement, many drugs that have been approved by FDA have limited efficacy (eg, drugs that treat cancer or Alzheimer’s disease). In many cases, some portion of the limited efficacy is […]
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Paper Submissions: Going, going…away

In order to fulfill a requirement specified in Section 745A(a) of the Food and Drug Administration Safety and Innovation Act (aka FDASIA), FDA recently issued a draft guidance directing mandatory use of electronic filing and formatting for most regulatory submissions which currently can still be submitted in paper format.  The change is not exactly imminent, but […]
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MannKind Breathes Easier – Inhaled Insulin Finally Approved

MannKind’s Afrezza Receives FDA Approval In June of this year, MannKind Corporation announced that they received FDA approval for Afrezza®, their rapid-acting inhaled insulin product. MannKind is currently working to identify a pharma partner to manufacture and distribute Afrezza, and the product could be available as soon as January 2015. This approval has been a […]
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Importing pre-launch products with a bit of PLAIR

With the tsunami of activities connected with the initial implementation of all the GDUFA requirements, another change made by FDA went largely under the radar.  FDA released the draft guidance, “Pre-Launch Activities Importation Requests (PLAIR)”. (CDER July 2013) which describes how an NDA/ANDA applicant may import finished dosage forms into the United States prior to […]
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The Road to Commercial Success – The Target Product Profile

The goal of drug product development is commercial success.  If this statement wasn’t true, how would patients access the live-saving or life-enhancing drugs we are developing.  Yet, all too many companies focus just on FDA approval, which in our view should be just a very important milestone. When embarking on the drug development journey, it is […]
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Top Generic CEO’s confirm importance of 505(b)(2) in their company’s financial future

Development stage companies are seeing more opportunities to license their products to generic companies.  Recently, generic company CEOs reinforced the importance of 505(b)(2)-developed products to their financial future. The 2014 Generic Pharmaceutical Association (GPhA) annual meeting concluded this pastweek in Orlando.  This is the largest gathering of C-level executives from the generic industry.  Camargo has exhibited and I […]
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2013 505(b)(2) NDA Approvals

2013 appears to be a challenging year for FDA NDA approvals.  FDA’s John Jenkins reviewed the  NME NDA and BLA approvals through November 2013, showing that 25 such products were approved (see chart below).  These 25 approvals are 505(b)(1)NDA and BLA’s.  Generally, this performance was seen as disappointing, but readers of this blog know that the number […]
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Expensive, cheap, value? CMO costs.

Contract manufacturing organization (CMO) A bids $600,000.  CMO B bids $450,000.  Which bid is cheaper? Assume for the moment that both CMOs provide equal service parameters: skill, capacity, timelines, regulatory history, experience, etc. and we are judging both based only on price. No, this is a not trick question.  But the result is not obvious. Even with a detailed […]
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ANDA but No NDA – What to Rely on?

Camargo participates in 2-5 PIND meetings each month and one thing we notice in the FDA minutes is that the boilerplate answer to ‘does the Agency agree this ….. is appropriate for filing under 505(b)(2)?’ keeps getting longer.  Recently, the Agency (or, at least, some divisions) is informing sponsors that they cannot use a product approved under […]
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PREA – Pediatric Plan Timing Changed by PDUFA V

The Food and Drug Administration Safety and Innovation Act (FDASIA; also known as PDUFA V), signed into law on July 9, 2012, contains amendments to the Pediatric Research Equity Act (PREA) that specifically detail the timing of the submission of a Pediatric Study Plan (PSP). In order to direct greater adherence to the PREA requirements before […]
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FDA Goes Against Advisory Committee and Approves Low Dose Paroxentine for Hot Flashes

On 6/30/2013, FDA approved Noven Pharmaceuticals Brisdelle (paroxetine) for the treatment of vasomotor symptoms (hot flashes).  This 505(b)(2)  approval is notable since it is the first non-hormonal product product approved for this indication. But from a regulatory point of view, it is even more interesting – FDA went against a 10-4 Advisory Committee vote against […]
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FDA Rejects Depomed’s Gabapentin for Menopausal Symptoms

FDA concurred with its Advisory Committee’s recommendations and has turned down Depomed’s application seeking a new indication for gabapentin.  Depomed has sought approval to use the drug in the treatment of menopausal symptoms – ‘hot flashes’. We reviewed the Advisory Committee’s deliberations in this blog this past April.  The drug failed to show superiority over placebo.  […]
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505(b)(2) Prodrug Fails Phase III Study

Development of drugs for new indications entails more risk of failure than simply changing formulations.  Just ask XenoPort, which announced May 19th that its prodrug of R-baclofen, arbaclofen placarbil,   failed to show efficacy in a Phase III clinical trial. Arbaclofen placarbil was being studied for multiple sclerosis-related spasticity. Racemic baclofen,  now generic, is indicated for treating muscle […]
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Don’t conduct unneeded tox studies

In April I presented a webinar under the auspices of the DIA concerning preclinical bridging. During this webinar, we discussed the need to fill the toxicology gaps that may have been created during the time since the original reference listed drug was approved. These gaps, I stated, has led to the unfounded belief that the […]
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Merck Uses 505(b)(2) for New Combo

On May 3, 2013 FDA approved Merck’s  Liptruzet, which combines the its Zetia (ezetimibe) and atorvastatin – Pfizer’s Lipitor which has gone generic.  According to the Merck press release, Liptruzet was approved “for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone […]
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Raptor’s Procysbi Costs More Than A Generic (!)

Again we have the media troubled by new, improved drugs that cost more than the generic they are based on rather than trumpeting the improvements.  Raptor Pharmaceutical received approval of its Procysbi (cysteamine bitartrate) for the treatment of  nephropathic cystinosis, an orphan disease affecting an estimated 500 patients in the U.S.  FDA approved Procysbi under 505(b)(2) on April […]
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Non-clinical bridging – Most 505(b)(2)’s Don’t Require Full Tox Package

I have just finished a webinar under the sponsorship of the DIA dealing with non-clinical bridging. In this post, I’d like to share one of the case studies from my presentation to illustrate what should be considered during development. The example is the development of gabapentin enacarbil by XenoPort/GSK for restless leg syndrome. Gabapentin enacarbil […]
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New PDUFA V Meeting Timelines

PDUFA V ushered in new industry and FDA commitments.  Among these are changes in meeting timelines. A significant change from PDUFA IV is the timeline for Type A meetings. Under PDUFA IV the meeting package was due 30 days in advance of the meeting.  Now, under PDUFA V, this package is due at the time of […]
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Advisory Committee Cool on Non-Steroid Hot Flash Treatments

The Camargo team got its start in the 505(b)(2) process at Duramed Pharmaceuticals with the 1990’s development and approval of Cenestin (synthetic conjugated estrogens, A).  The product was approved based on a Phase 3 clinical study demonstrating the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause –   (known as ‘hot flashes’).  For decades, estrogens have […]
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Orphan Designation Granted Letter

Camargo is privileged to work with many clients to develop Orphan drugs.  In order to obtain an Orphan drug approval the sponsor must first request that the drug and indication be granted orphan-drug designation.  This process requires research into both the indication and the potential population.  If the FDA’s Office of Orphan Products Development agrees, […]
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Are 505(b)(2)’s “Super Generics” or what do we call them?

When we started Camargo almost 10 years ago, products approved under 505j were called ‘generics’ and 505(b)(1) ‘new drugs’.  We could find no consensus of a name for products approved via 505(b)(2). Of course, when Camargo started business, there had been very few 505(b)(2) products approved.  Fast forward 10 years and we have seen an explosion of 505(b)(2) products […]
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KV Appeals Makena Decision

We have followed the saga of KV’s Makena for two reasons.  The most important reason is that the submission, review and approval of Makena is perhaps the best example of using a publicly funded clinical study for NDA approval, despite the clinical trial material not being sourced by the sponsor of the NDA.  The other reason is […]
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No 5-Year Exclusivity for Combinations Drugs with an NCE

One anomaly to the exclusivity rules is that a combination drug product containing a new chemical entity (NCE) and one or more previously approved drugs does not receive the 5-year exclusivity that a single-component NCE drug would receive. Thus, Ferring Pharmaceuticals Prepopik (sodium picosulfate, citric acid and magnesium oxide) was approved as a 505(b)(2) in July, 2012, […]
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2013 GDUFA Fees

FDA has published the 2013 GDUFA fees: Finished Dosage Form (FDF) :  Domestic: $175,389  Foreign: $190,389 API:                                       Domestic: $26,458    Foreign: $41,458 These fees are due by March 4, 2013.
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2012 505(b)(2) Approvals – Record Year

Nice going!  2012 saw a record number of 505(b)(2) drugs approved – 47.  As is usual at this time of the year, I have prepared a listing of all of the approvals. This year, I have made the listing more useful – the table is now sortable and now contains a hyperlink to both the […]
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Suit to challenge use of REMS to block generics and 505(b)(2)

Innovators have used REMS to block generic and 505(b)(2) developers from gaining access to the reference listed drugs (RLD), effectively blocking their development.  The 2012 Congress failed to pass legislation to force innovators to provide access to the RLD’s.  FDA believes it has no authority to assist.  In fact, FDA refuses to reveal if the […]
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Off-label promotion: Free Speech?

Announcement of the decision from the US Court of Appeals for the Second Circuit in the United States v. Alfred Caronia generated a lot of discussion this past week, as well it might.  The appellate court overturned the criminal conviction of pharmaceutical sales representative Alfred Caronia for off-label promotion of Xyrem, prescribed primarily to prevent narcolepsy.  […]
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Orphan Designation without Exclusivity: Court asked to decide

Yesterday, Depomed filed suit against the FDA requesting the Court to order FDA to grant their product Gralise (gabapentin) 7 years of exclusivity since it was granted Orphan status; upon approval, Gralise was granted 3 years of exclusivity. Depomed licensed the product to Solvay which became Abbott via acquisition.  Thus the majority of NDA-related regulatory […]
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New Generic Stability Requirements

After much delay, FDA just released the new Guidance on the stability requirements to file and obtain approval of a generic drug product and API under 505j.  The new requirements bring ANDAs closer in line with NDAs and ICH.  The new requirements as summarized in the Guidance are: 1. Submit data from three pilot scale batches […]
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Court dismisses KV’s suit against FDA

Yesterday 9/6/2012, the U.S. District Court for the District of Columbia dismissed KV Pharmaceutical’s suit against the FDA.  KV had asked the Court to force FDA to stop the marketing of compounded versions of 17-hydroxyprogesterone caproate cream and related imported API.  FDA countered with the argument that the Courts cannot force the FDA to take […]
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K-V Pharma bankrupt – Claims FDA Doesn’t Back Makena

K-V Pharmaceuticals filed for Chapter 11 bankruptcy. After years of GMP issues narrowed the product offering to just one product, Makena (17-hydoxyprogesterone caproate), poor sales of the product couldn’t sustain the company. In this blog I have discussed the filing and approval of Makena, a product for pre-term labor.  Prior to this approval, the product had been available […]
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Generic of 505(b)(2)

There are not many instances of a generic version of a reference drug approved via the 505(b)(2) pathway.  Last Friday, FDA approved Watson’s generic of Teva’s Plan B One-Step [progestin].  Watson will call its version Next Choice One Dose. For history and industry buffs, Plan B was originally developed under the Duramed brand Barr Pharmaceuticals, […]
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REMS in Congress

I’m not into politics, but maybe some of my readers are and wish to contact their representative in the U.S. House of Representatives to share your thoughts on a pending issue. With the introduction of REMS, innovator companies have used the restricted distribution feature to prevent other pharmaceutical companies from obtaining drug supplies that can […]
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ViroPharma loses exclusivity appeal

As I wrote last week, on 4/9/12 the FDA denied ViroPharma’s request for 3-year exclusivity for its antibiotic Vancocin and approved three generics.  ViroPharma immediately sued the heads of FDA and HHS and their Agencies.  In a U.S. District Court decision, the judge denied ViroPharma’s motions to grant a  preliminary injunction to require that FDA withdraw the ANDA […]
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ViroPharma denied request for 3-year exclusivity

ViroPharma has pulled out all stops to prevent generic copies of its off-patent Vancocin® capsule (vancomycin hydrochloride) including the use of the Citizen Petition process.  Recently, FDA denied most of the requests  in their Citizen Petition and simultaneously approved generics from 3 companies.  ViroPharma immediately responded by filing a suit against the FDA. A reading of the […]
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Drug Development Planned Like the Titanic

How many drug development companies leave it up to the CRO or CMO to design or execute their studies or formulation/manufacturing without oversight?   Like those who boarded the Titantic 100 years ago, they seem to trust the mantra that their contractor’s work is unsinkable.  MAP Pharmaceuticals seemed to do just that – the approval of their […]
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NIH Head Urges Repositioning/Repurposing

In a speech at yesterday’s 2012 TEDMED conference, the head of the NIH, Dr. Francis Collins, said  that there is a big gap between basic research and drugs for patients.  To bridge this gap he suggested ‘some of those old drugs could be re-purposed — or taught new tricks’ – hey, that’s our tag line! […]
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Generic vs. 505(b)(2) Failure-to-Warn Liability

A recent editorial (may need subscription) in the New York Times opined that a recent Supreme Court decision – a “bizarre outcome” – “makes it virtually impossible to sue generic manufacturers for failing to provide adequate warning of a prescription drug’s dangers.”   The court case the Times is referring to is Pliva Inc. v. Mensing .   In […]
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2011 505(b)(2) Approvals Now Exceed 505(b)(1) NDA Approvals

What a year for 505(b)(2) drug development!  In 2011 FDA approved 44 505(b)(2) NDA submissions.  Various authors have reported that FDA approved 34 or 35 drugs in 2011 (505(b)(1) NDA + BLA).  I had speculated a couple of years ago that perhaps 80% of new drugs approved  in 2012 would be 505(b)(2)’s, based on botha  […]
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What is an Approved DESI Product?

I am hesitant to contribute more information about so-called DESI drugs at the risk of further confusion.  My goal is always to provide clarity, so here goes. Fundamental to any discussion about DESI products is the definition of a drug product.  Let’s just focus on one part of the definition – the labeling.  A drug […]
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Stability Changes coming to ANDAs

This post comes from D.C. where I am attending the GPhA Fall Technical Conference.  We just completed a presentation by FDA’s Glen Smith.  He  detailed the proposed new stability requirements for ANDA drug products.  It is essentially the adoption of ICH Q1A.  For readers of this blog, we know that 505(b(2) NDA’s must have 12 months […]
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Don’t launch unapproved products after 9/19/2011

I had a call from a client who wondered if he could launch a new ‘DESI’ product. He had just read the FDA’s recent announcement that it would take immediate enforcement action on any unapproved drug introduced into the market after September 19, 2011. So, the question he asked was, is his “DESI” drug an […]
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AB Rated 505(b)(2)’s

Can you have an “AB” rated 505(b)(2)?  Yes, as well as other Therapeutic Equivalent (TE) codes that are most often associated with the TE codes for generics in the Orange Book. Several years ago when I was speaking about the potential products that qualified under 505(b)(2) I had a line in a PowerPoint slide for […]
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