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Fluvoxamine maleate is a selective serotonin reuptake inhibitor, which was originally developed in Switzerland in 1983 and has been marketed in Japan since 1999.
This is the world's first such indication approved for fluvoxamine maleate.
Important Information About Fluvoxamine Maleate ER Capsules Fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV.
Most recently, Solvay Pharmaceuticals submitted a New Drug Application (NDA) in April 2006 to the FDA for fluvoxamine maleate extended-release capsules, an investigational compound being studied for the treatment of generalized social anxiety disorder (SAD) and obsessive compulsive disorder (OCD) in adults.
Fluvoxamine maleate is the generic equivalent to Solvay Pharmaceuticals' Luvox(R) tablets, which are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder.
Food and Drug Administration to market Fluvoxamine Maleate 25mg, 50mg and 100mg Tablets.
NYSE:MYL) announced today that the Food and Drug Administration has approved Mylan's abbreviated new drug application (ANDA) for Fluvoxamine Maleate Tablets in 25 mg, 50 mg, and 100 mg strengths.