Each month, Camargo’s “In the News” series will highlight important changes and advancements in the regulatory and development space and explore how those changes could impact your program. FDA announces intention to resume domestic inspections Camargo recently examined an FDA Complete Response Letter which required
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
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
Drug shortages can have serious and immediate effects on providing needed therapies to patients, and preventing shortages is a current priority for FDA. FDA has taken a variety of actions to eliminate, mitigate, and prevent shortages (Executive Order 13588; Interim Final Rule; and Draft Guidance
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
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
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,
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
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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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