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 chemical [...]
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You are currently browsing the Drug Kennel weblog archives for the day Tuesday, December 16th, 2008.
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- Failed 505(b)(2)?: Vivus’ Qnexa
- Will We Have Generic User Fees? Public Meeting To Be Held.
- Lannett’s Morphine Sulfate Oral Solution: 505(b)(2) or 505j?
- Generic Lovenox – 505j or 505(b)(2)
- New User Fees for 2011
- Still submitting paper ANDA applications?
- What should a license cost?
- Avandia: Who Won?
- Advisory Committee Meeting: Rosiglitazone
- The skinny on a potential new treatment of obesity
Fenofibrate (TriCor) active metabolite approved
Published December 16th, 2008 in News Commentary. 1 CommentIn a previous posting we commented on the battle between Abbott and Teva over Abbott’s generic defense strategy. Yesterday (12/15/2008), FDA approved Abbott’s TriLipix - fenofibric acid. Fenofibric acid is the active metabolite of fenofibrate. The approval includes an indication to allow use in combination with a statin. In fact, it was announced that Abbott [...]