Biovail Corporation said 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.