Teva wins FDA approval for generic Serzone

Serzone, developed by Bristol-Myers Squibb for the treatment of depression, has annual sales of about $220 million.

Drug maker Teva (Nasdaq: TEVA) announced on Tuesday that it received Food and Drug Administration (FDA) approval to market its generic version of Serzone, Bristol-Myers Squibb Co.'s (NYSE: BMY) drug for the treatment of depression.

The brand product has annual sales of about $220 million, Teva said.

Teva will not market the drug exclusively, as the FDA has also approved marketing applications for generic Serzone from Par Pharmaceuticals (NYSE: PRX), EON Labs (Nasdaq: ELAB), IVAX Corp, Mylan Laboratories (NYSE: MYL) and Watson Pharmaceuticals (NYSE: WPI).

The approval for Teva covers 50 milligram, 100 mg, 150 mg, 200 mg and 250 mg tablets of Nefazodone hydrochloride, which affects levels of serotonin, a mood-regulating brain neurotransmitter.

Teva’s Nasdaq shares closed on Tuesday up 2.3% at $59.48. In early trading on Wednesday, Teva’s Tel Aviv share was up 2% at NIS 267.80.

Published by Globes [online] - www.globes.co.il - on 17 September, 2003

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