Mylan gets approval for generic Betapace AF
Pittsburgh Business Times
Mylan Laboratories Inc. said it received final approval from the U.S. Food and Drug Administration for the abbreviated new drug application for sotalol hydrochloride, which is used to treat ventrical arrhythmias.
Sotalol hydrochloride tablets AF are the generic version of Berlex Inc.'s Betapace AF tablets, Cecil Township-based Mylan (NYSE:MYL) said in a statement.
Berlix is a U.S. affiliate of Bayer Schering Pharma.
Mylan will immediately ship 80-milligram, 120-milligram and 160-milligram tablets of sotalol hydrochloride AF.
Betapace had U.S. sales of approximately $10.5 million for the same strengths in the 12-month period ending Dec. 31, 2006, according to IMS Health, a Fairfield, Conn.-based provider of data for the pharmaceutical industry.
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