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