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Noven Gets Tentative FDA Approval For Stavzor

Thursday, December 27, 2007 5:17:00 AM PDT | VentureDeal Staff
MIAMI, FL -- Noven Pharmaceuticals, Inc. (Nasdaq: NOVN) announced that it has received tentative FDA approval for its New Drug Application (NDA) for Stavzor in a variety of dosages.

Stavzor is slated to be used for the treatment of manic episodes associated with bipolar disorder, monotherapy and adjunctive therapy in multiple seizure types and prophylaxis of migraine headaches.

The FDA approval means that it has tentatively approved the drug, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States.

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