UPDATE 1-U.S. FDA approves Biovail drug for depression
(Adds Biovail comments, background)
WASHINGTON, April 23 (Reuters) - U.S. regulators approved Biovail Corp's (BVF.TO) Aplenzin extended-release tablets for treating depression, a Food and Drug Administration spokeswoman said on Wednesday.
The drug's generic name is bupropion hydrobromide, FDA spokeswoman Sandy Walsh said. It was formerly known as BVF-033.
Bupropion is the active ingredient in the antidepressant Wellbutrin XL, which is manufactured by Biovail and sold by GlaxoSmithKline Plc (GSK.L).
Aplenzin is a new formulation of bupropion that, at the highest approved strength, "provides patients requiring the maximum allowable dose of bupropion the only single tablet, once-daily option," Biovail said in a statement.
The drug also is alcohol resistant, which means alcohol does not accelerate the medicine's release into the body, Biovail spokesman Nelson Isabel said. That can happen with some other antidepressants.
Biovail, Canada's biggest publicly traded drugmaker, said it "remains in active partnership discussions for the commercialization rights for Aplenzin in the United States." (Reporting by Lisa Richwine; Editing by Andre Grenon)
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