2009 505(b)(2) Approvals

2009 saw a record number of 505(b)(2) approvals. A total of thirty-three (33) 505(b)(2) NDA’s were approved by FDA in calendar 2009:

  • 23 new formulations
  • 1 New Molecular Entity
  • 5 new combinations of existing drugs
  • 4 drugs already marketed, but without an approved NDA

We track approvals on this blog as they occur (click here to see my entire list of approvals* and a link to the FDA approval letters). Approvals that have particular interest also get a separate post in this blog.

We don’t track 505(b)(1) approvals. However, it was widely reported that FDA approved 26 (b)(1)’s in 2009, up from 25 in 2008. This means that 56% of the new drugs approved in 2009 were 505(b)(2)’s. Who would have thought that 505(b)(2) approvals would be in the majority? In 2007, according to a calculation by Art Pappas of pappas ventures, 43% of the new drug approvals were 505(b)(2)’s. We predict that by 2012, about 80% of drug approvals will be 505(b)(2)’s. The percentage increase will be due mainly to a numerical increase in 505(b)(2) approvals and a decrease in 505(b)(1)’s as major pharma moves to biologics.

New Formulations

Twenty-three (23) new formulations of existing drugs are approved via 505(b)(2) in 2009. The sponsors included some expected large pharma (Novartis, Shire, and Allergan) but many small pharma. We expect that more small companies will receive approvals in the coming years. The changes from the RLD included route of administration, dosage form and duration of action. In our opinion, almost all of the products make a meaningful contribution to the practice of medicine. As is their right, Abbott continued the dance with fenofibrate (TriCor) making changes to maintain their market monopoly — they got fenofibric acid approved. Separately, Abbott settled with Teva over generic issues (see this opinion piece for further background).

New Molecular Entity

Just one (1) NME was approved in 2009 under 505(b)(2). Benzyl alcohol, an excipient used in thousands of products, including cosmetics and OTC products, was the subject of an approved NDA for use in the treatment of head lice. Sciele Pharma Inc., well-known for using the 505(b)(2) pathway acquired this product from Summers Laboratories in 2007. Congratulations to Sciele on getting 5 years exclusivity. Among all of the products approved in 2009 by 505(b), this product was also one of the few that is targeted at treating pediatrics. The lack of approved pediatric products is a national shame.

New combinations of existing drugs

There were five (5) new combination drugs approved via 505(b)(2) in 2009. Notable was the approval of the combination morphine sulfate and naltrexone by King Pharmaceuticals. This approval is being used as a reference example/model by many sponsors trying to reduce the abuse of opioids.

Drugs already marketed without an approved NDA

Four drugs were approved in this category in 2009. Indeed, the same API — pancrelipase (pancreatic enzymes) were the subject of NDA’s submitted by Solvay and Eurand (different dosage forms). The widely used codeine sulfate was finally approved as an NDA after over a century of use as a drug. We expect the number of approvals of ‘unapproved drugs’ to increase greatly over the next couple of years. Some of these approvals will come from our work with clients. As detailed in this blog, FDA initiated an effort to remove these unapproved products (mainly DESI) from the market in early 2008. Given the 2-3 year development and 10-month regulatory review timeframes, we expect a rise in these approvals beginning in the middle of 2011.

*A disclaimer: I am solely responsible for any errors, inclusions or omissions in my list. I use the monthly approval reports from the FDA and examine the approval letter for evidence that the product approval was based on 505(b)(2). The FDA makes errors too and I investigate the approval through other publicly available documents. Moreover, the FDA does not always indicate whether an approval is based on 505(b)(2) or 505(b)(1), simply indicating 505b. Please bring errors to my attention.

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