Biovail Corporation announced that Aplenzin (bupropion hydrobromide) extended-release tablets are now available by prescription in the United States for adults ages 18 and older. Aplenzin, which was developed by Biovail, offers prescribeers and their patients the benefit of convenience with simple one-tablet, once-daily dosing of bupropion at all doses.
Aplenzin was approved by the US Food and Drug Administration (FDA) in April 2008 at dosage strengths of 174mg, 348mg and 522mg for the treatment of major depressive disorder (MDD). The 522mg dosage strength of Aplenzin represents the only FDA-approved single-tablet, once-daily treatment option equivalent to 450mg of bupropion hydrochloride therapy, which requires two or three tablets daily.
In December 2008, Biovail entered into a supply-and-distribution agreement with sanofi-aventis US, which is now marketing the product in the US and Puerto Rico. Under the terms of the agreement, Biovail will manufacture, supply and sell Aplenzin to sanofi-aventis US at contractually determined prices, which will be based on sanofi-aventis US' net selling price. Biovail's supply price will range from 25 to 35 per cent of net sales, depending on the level of net sales of Aplenzin.