FDA Approves Biovail Corporation (BVF) Drug for Depression
TORONTO -- Biovail Corporation announced today that it has received Approval from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for Aplenzinâ„¢ (formerly known as BVF-033), a once-daily formulation of bupropion hydrobromide developed by Biovail for the treatment of depression in adults.
Aplenzinâ„¢ 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 Aplenzinâ„¢ 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. For more information about Biovail, visit the Companyâ€™s Web site at www.biovail.com.
For further information, please contact Nelson F. Isabel at 905-286-3000 or send inquiries to [email protected]