Approvable Letters – A Conversation with Myself…

J0402585I am posting a podcast which, unlike past efforts, is not an interview, but a short discussion on my take on approvable letters. 

What makes an approvable letter more likely than an approval letter for investigational products? 

While there is no set formula – and no one is a fortune teller, I have worked with a number of companies on building their case for approval before an FDA Advisory Committee meeting, and I’ve looked at outcomes.  So in today’s podcast, I’m going to give you my take on what factors to consider when pondering the potential outcome of a candidate investigational product for FDA approval.

By the way, while a great deal of attention was focused by investors last week on the announcement by Dendreon that it had received an approvable letter from the FDA for Provenge, many others have been issued by the FDA recently.  Here are some of the others:

  • Merck – 5-11-07 – NDA for EMEND (fosaprepitant dimeglumine) – an investigational intravenous therapy for chemotherapy-induced nausea and vomiting (CINV).  According to the release by Merck the FDA wants "additional manufacturing validation and stability data" as well as "certain additional data"… An oral formulation is already in use. 
  • Cipher Pharmaceuticals – 5-3-07 – NDA for CIP-Tramadol ERCipher Pharmaceuticals announced an approvable letter for its once-daily formulation of tramadol, saying that the FDA has asked for the "resolution of certain issues, including chemistry, manufacturing and controls and a request for an additional adequate clinical trial to provide further efficacy data."
  • Wyeth –  4-24-07 – NDA for Bazedoxifene – A SERM treatment for the prevention of postmenopausal osteoporosis was deemed approvable by FDA.  According to the release, the FDA
    • must receive and analyze, as part of its benefit-risk assessment, final safety and efficacy data from the recently completed Phase 3 treatment study of bazedoxifene, which was discussed during the Company’s earnings call last week.      
    • must complete an acceptable establishment evaluation for the manufacturing and testing facilities for bazedoxifene.  The FDA concluded its general re-inspection of Wyeth’s Guayama facility in early April, and Wyeth has provided a written response to the FDA’s observations.  We believe the situation at the Guayama facility will be resolved without affecting the timing of new product launches.
This entry was posted in Approvable Letters, Podcast. Bookmark the permalink.

1 Response to Approvable Letters – A Conversation with Myself…

  1. Kerry Donahue says:

    Approvable letters and denial letters functionally act in the exact same way.
    The FDA created approvable letters only as a mechanism to avoid Congressional and Court oversight.
    Its a con job on America!
    Houdini would be proud of that trick!
    Gotta hand it to FDA counsel though, they have done their job well.

Comments are closed.