Noven gets approvable letter

The FDA has issued an approvable letter for Noven Pharmaceutical's Stavzor, a treatment for manic episodes associated with bipolar disorder, an adjunctive therapy in multiple seizure types, and prophylaxis of migraine headaches. The FDA wants non-clinical information, including additional in vitro dissolution data, as a condition to final approval. The good news for Noven is that the agency won't require any additional human studies or clinical data. Noven says that it is anticipating full approval by July 2008.

- see this release from Noven

Suggested Articles

Ipsen's new hire arrives at a company reeling from a torrent six months that have crushed hopes for its $1 billion bet on a rare disease drug.

Leaders from four of the biggest drugmakers in the world spoke about rising to the challenge of defeating the global pandemic.

Bristol Myers Squibb is teaming up with Repare Therapeutics to find new synthetic lethality targets in a deal that could be worth billions.