Mylan Generic Heart Drug Cleared By FDA
February 9, 2007
Mylan Laboratories has received final approval from the Food and Drug Administration for its abbreviated new drug application for sotalol hydrochloride tablets.
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.