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news.Biovail has received approval from the FDA for its new drug application for Aplenzin, a once-daily formulation of bupropion hydrobromide, developed for the treatment of depression in adults.
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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 US.