Caraco gets FDA approval to market fluvoxamine maleate tablets

By Ted A. Knutson

Washington, Feb. 24 - Caraco Pharmaceutical Laboratories, Ltd. announced Friday the Food and Drug Administration has granted final approval for the company's abbreviated New Drug Application for fluvoxamine maleate 25 mg, 50 mg and 100 mg strength tablets.

Fluvoxamine maleate is marketed domestically as a selective serotonin (5-HT) reuptake inhibitor class. Fluvoxamine maleate tablets are indicated for treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder.

"We plan to launch this product to the market immediately," said Daniel H. Movens, Caraco's chief executive officer, in a press release. "This approval brings our total product portfolio to 20 different products, represented by 44 different strengths."

Detroit-based Caraco Pharmaceutical Laboratories develops, manufactures and distributes generic and private-label prescription pharmaceuticals to the nation's wholesalers, distributors, drugstore chains and managed care providers.

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