DESI Drug Resources

DESI Drugs: Potential Targets for Quick Approvals

DESI Drugs: potential targets for quick approvals Drugs that are on the market but are not approved by the FDA are more common than you might think. Even some physicians might be unaware that the drug they are prescribing has not been approved, meaning it has not undergone the rigorous standards of safety and efficacy […]
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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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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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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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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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505(b)(2) Product Gains Revenue with FDA Actions Against DESI’s

Eurand reported improved financial performance for the 1st quarter of 2010. CEO Gearoid Faherty indicated the majority of the revenue gains could be attributed to Zenpep®, Eurand’s delayed-release pancreatic insufficiency drug. Zenpep was approved in August 2009. The FDA has recently clamped down on unapproved pancreatic enzymes that have been on the market for years. […]
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DESI to 505(b)(2) Raises Drug Costs

FDA is trying to remove unapproved new drugs from the market. This past year the FDA approved URL’s colchicine. Previously, FDA announced it was taking action against unapproved colchicine on the market. We have commented on these actions in this blog. A recent article in Kaiser Health News questions whether the approval of these DESI […]
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Getting Unapproved Drugs (DESI, etc.) Approved

FDA uses the term ‘Unapproved Drugs’ to refer to any drug that is marketed in the U.S. without FDA approval.  There are hundreds, maybe thousands of these drugs in the U.S..  We have written about the efforts of FDA to remove them from the market.  But also FDA has devoted a lot of resources to […]
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Qutenza: Approval of a “DESI-inspired” Drug

This week, NeurogesX, Inc. announced the FDA 505(b)(2) approval of Qutenza(TM), its 8% capsaicin patch, for management of post-herpetic neuralgia (PHN) – the nerve pain that can follow an attack of shingles. While not strictly speaking a DESI product, Qutenza can be considered “DESI-inspired,” because it is a first Rx approval for an active ingredient […]
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Codeine Sulfate: FDA continues drive to remove unapproved products, with a twist

Yesterday, October 13, FDA sent Warning Letters  to four manufacturers of Codeine Sulfate tablets, 30 and 60 mg:  Lehigh Valley Technologies, Inc., Cerovene Inc., Dava International, Inc., and Glenmark Generics, Inc., for marketing a product without an approved application.   The manufacturers have 15 days to cease manufacturing, and distributors have 180 days to cease further shipment.  […]
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More DESI Tannates removed from market

FDA continues to remove unapproved DESI products from the market.  Generally, it appears that the removals occur when the manufacturing site is inspected and the FDA identifies unapproved products being made.  The latest manufacturer to be hit is ANIP Acquisition Company.  During an inspection of the firms facilities in Gulfport, MS this past February, the […]
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DESI Presentation: Q&A

Today I conducted an audio conference entitled: FDA banning DESI Drugs-Submissions Strategies to Keep Yours on the Market.  I know, a bit aggressive, but it’s also a crowded market.  Judging from the questions, most attendees are current DESI producers looking to gain knowledge of the pathway to FDA approval.  As we have tracked in this […]
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What are DESI Drugs?

A reader pointed out that I have never defined DESI drugs, despite several posts that contained references to them.  DESI drugs are a great source for 505(b)(2) development since many will qualify for 5 years data exclusivity. Once upon a time…. In 1938 the FD&C Act was established that required that drugs be proven safe before […]
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DESI + non-cGMP = Recall

FDA is clamping down  on DESI’s, but to date we have seen FDA only stop manufacturing and distibution.  Until now.  On April 20, 2009, Neilgen Pharmaceuticals and its parent Advent Pharmaceuticals were forced into a recall of 13 cough/cold medications.  All of the cough cold medications are tannate salts of common ingredients.  It is one […]
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FDA Stops DESI Unapproved Rx Narcotics

Yesterday, 3/31/09, FDA sent warning letters to nine pharmaceutical companies  to stop manufacturing 14 unapproved narcotic drugs.  These drugs are unapproved because they were made without NDA or ANDA approvals, falling under the category of DESI or grandfathered drugs. Warning letters were sent to the following companies (I have listed the affected drug products for […]
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What is an NME?

People are often surprised when I tell them that 505(b)(2) applications can contain a new molecular entity (NME).  In fact, a 505(b)(2) covers any NDA application that relies on pivotal efficacy or safety information that the sponsor does not own the rights to. So what is an NME? Under FD&C 505(c)(3)(D) and 505(j)(5)(D) “a new […]
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Medicaid paid for unapproved DESI drugs

A minor ripple in the media, the Associated Press reviewed Medicaid records and found that since 2004, Medicaid has paid at least $200 million for unapproved drugs (perhaps $50MM per year).  “Unapproved” sounds scary, right?  These drugs are DESI drugs that are not normally reimbursed.  $200 million pales in comparison to the amounts that Medicaid has paid.  For […]
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Drug Repositioning Summit 2008

Camargo was one of the sponsors of Cambridge Healthtech Institute’s Drug Repositioning Summit last week (Oct. 6-7, 2008).  I woke the group up on the second day with a breakfast talk entitled “505(b)(2) Experiences – The Journey Continues”.  I reviewed some of the important changes over the last few years that the FDA has made […]
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Another DESI in Discretion

Ever since FDA gave notice about Marketed Unapproved Drugs, manufacturers of these drugs have been wondering when the shoe would drop on their products.  Basically, the FDA has said that eventually these products must be removed from the market.  Since the FDA does not have sufficient resources, it will remove products it deems most hazardous.  […]
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More DESI-products cited. Exceptions are noted for unique products.

FDA inspections and citations sometimes take a few weeks to appear on the FDA website. So, “news” is a erlative term here.  Nonetheless, activity related to DESI drugs has a keen interest to us because they represent FDA thinking and potential 505(b)(2) projects. A July 24 Warning Letter was issued by FDA to G & W […]
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KV’s DESI Guaifenesin Trumped by Adam’s 505(b)(2) Product

Last week (7/30/2008) , FDA announced that it seized timed-release guaifenesin products from KV Pharmaceutical.  In 2002 the FDA determined this DESI product to be a safety hazard to children.  The manufacturers, including KV Pharmaceutical (Warning Letters: see page 23)  were told to stop manufacturing by November 2003 unless they received NDA approval.  Adams Respiratory Therapeutics obtained NDA […]
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Is your drug project a 505(b)(2), ANDA or OTC?

I get a lot of requests to assure people that their project is, or is not, a 505(b)(2).  A few questions about whether it is an OTC candidate. The question about whether the proposed drug is a 505(b)(1) or 505 (b)(2) is readily answered by the question: is any data essential for approval being obtained […]
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Another “unapproved” drug needs a 505(b)(2) approval

FDA is continuing to act on its promise made in January 2007 to remove products from the market that it considers unapproved.  These products, some stemming from the DESI process, have been with us many years. The latest casualty is Colchicine for Injection.  On February 6, FDA announced it was taking enforcement action because the […]
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New Safety Reporting Requirements for Unapproved OTC products

We’ve been observing the FDA crackdown on unapproved DESI and OTC drugs.  The reason that Congress and FDA have made these moves is a concern for safety.  Industry counters that these drugs have been used safely for years.  Frankly, there is a lack of data to support either side.  Approved drugs have always been subject […]
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Adams “DESI” Product Approvable

Adams Respiratory Therapeutics announced that it received an Approvable letter from FDA on 10/29/07 for its guaifenesin 600/1200 mg and codeine phosphate 30/60 mg extended-release bi-layer tablets.  The release indicates that the FDA needed additional data to support the use of the product with food. The proposed product is one of several currently on the market […]
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CNN Story on “Unapproved Drugs”

CNN ran a story today to  increase public awareness that there are hundreds of drugs consumed in the U.S. that have never been formally approved by the FDA. For professionals, the FDA has a web page devoted to this topic.  Some of these products were subject to the DESI review process, but it is well known that […]
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