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UPDATE 1-Noven says gets tentative approval for Stavzor

Wed Dec 26, 2007 6:22pm EST

Stocks  |  Regulatory News

(Recasts; adds details, share movement)

Dec 26 (Reuters) - Noven Pharmaceuticals Inc NOVN.O said U.S. health regulators gave tentative approval for its experimental drug, Stavzor, to treat bipolar disorder, migraine and epilepsy, sending its shares up 14 percent in late electronic trade.

Noven said it continues to expect the U.S. Food and Drug Administration's final approval of the drug by the end of July 2008.

The pending approval is for Stavzor in 125 mg, 250 mg and 500 mg strengths.

In October, the FDA had requested certain non-clinical information on Stavzor as a condition for final approval.

Shares of the company were trading at $16.50 in late electronic trade, after closing at $14.50 Wednesday on the Nasdaq.

(Reporting by Aditi Samajpati in Bangalore; Editing by Vinu Pilakkott)

((aditi.samajpati@reuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: aditi.samajpati.reuters.com@reuters.net)) Keywords: NOVEN/FDA

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