FDA Approves Biovail Corporation (BVF) Drug for Depression

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 Company’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]

Suggested Articles

Janssen’s BCMA-targeting CAR-T therapy eliminated tumors in 69% of patients with advanced multiple myeloma in a small phase 1 study.

In a study, BMS' CAR-T therapy banished tumors in more than half and shrank tumors in nearly three-quarters of relapsed blood cancer patients.

Novartis unveiled more data showing how its asthma combo QMF149 fared against the standard of care: a combination of the same types of drugs.