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news.Mylan Laboratories has received final approval from the Food and Drug Administration for its abbreviated new drug application for sotalol hydrochloride tablets.
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The drug has been approved in 80mg, 120mg and 160mg doses.
Sotalol Hydrochloride Tablets are the generic version of Berlex’s Betapace tablets, which had US sales of approximately $10.5 million for the same strengths in the 12-month period ending December 31, 2006, according to IMS Health.
Betapace is a heart drug that is designed to treat high blood pressue and irregular rhythms in the heart.
Mylan said the product would be shipped immediately.