Biovail Receives FDA Approval For Aplenzin (BVF-033) For The Treatment Of Depression

Main Category: Depression
Also Included In: Psychology / Psychiatry;  Mental Health;  Regulatory Affairs / Drug Approvals
Article Date: 25 Apr 2008 - 1:00 PDT

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Biovail Corporation (NYSE: BVF) (TSX: BVF) announced that it has received Approval from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for Aplenzin™ (formerly known as BVF-033), a once-daily formulation of bupropion hydrobromide developed by Biovail for the treatment of depression in adults.

Aplenzin™ is an alcohol-resistant formulation of a new bupropion salt and has been approved in 174mg, 348mg, and 522mg extended-release tablets. The 522mg dosage strength provides patients requiring the maximum allowable dose of bupropion the only single tablet, once-daily option.

Biovail remains in active partnership discussions for the commercialization rights for Aplenzin™ in the United States.

About Biovail Corporation

Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies.

Biovail Corporation