Apparently, the FDA is finishing up business for 2006 with a spate of activity. In addition to the three approvable letters noted last week, the FDA issued another approvable letter today to Nuvo Research Inc., Yahoo reports, for a topical NSAID product called Pennsaid to treat osteoarthritis of the knee. The company stock is sort of low, and has been for a while – it will be interesting to see how the announcement of an approvable letter affects it.
Apparently this is a step forward for the product, having received a non-approvable letter in 2002, according to the release. The company, seeking to pull a Lazarus, re-submitted the product for re-consideration in July 2006 after completing additional clinical trials. No word in the release on the reason for the approvable letter and what conditions the company must fulfill in order to gain approval. It is also noteworthy that if the company submitted in July, they are getting an action from the agency several months before their PDUFA date.
Along these lines, I will be updating and improving the Approvable Letter Chart, located at the link to your left to reflect the additions for this month so that it is completely up to date for the New Year.