FDA Approves Aplenzin
Biovail Receives FDA Approval for Aplenzin (BVF-033)
TORONTO--(BUSINESS WIRE)--Apr 23, 2008 - 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 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. 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.
Contact
Biovail Corporation
Nelson F. Isabel, 905-286-3000
Vice-President, Investor Relations
and Corporate Communications
Posted: April 2008
Aplenzin (bupropion hydrobromide) FDA Approval History
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