Noven Gets Tentative FDA OK for Stavzor

(December 26, 2007) Noven Pharmaceuticals Inc. said Wednesday the Food and Drug Administration tentatively approved its drug Stavzor for the treatment of manic episodes associated with bipolar disorder, epilepsy and migraine headaches.

"Tentative approval" generally means the FDA has concluded a drug product has met all required quality, safety and effectiveness standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States.

Noven said the application for Stavzor refers to Abbott Laboratories' drug Depakote, which is approved for bipolar disorder, epilepsy and migraines. Both products include a key ingredient called valproic acid.

If approved for marketing, however, Stavzor would be a branded rival, not a generic substitute for Depakote, Noven said.

Noven said based on the tentative approval letter and its understanding of Depakote's expiration of exclusivity, Noven continues to expect final FDA approval of Stavzor by the end of July 2008.

Wednesday's letter comes after the FDA in October issued an approvable letter for Stavzor asking for certain non-clinical information as a condition to final approval.

Noven acquired a license to market and sell Stavzor in the U.S., as part of Noven's acquisition of JDS Pharmaceuticals in August. The application for Stavzor was submitted to the FDA by High Point, Calif.-based Banner Pharmacaps Inc., which developed the product.

Source: The Associated Press

Last updated: 12/07

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