FDA APPROVES MYLAN'S ANDA FOR GENERIC BETAPACE

Mylan Pharmaceuticals has received final approval from the FDA for its abbreviated new drug application (ANDA) for sotalol hydrochloride tablets, 80, 120 and 160 mg.

Mylan's product is the generic version of Berlex's Betapace, which is used to treat atrial fibrillation. The brand drug had U.S. sales of approximately $10.5 million during the 12-month period ending Dec. 31, 2006, according to IMS Health data.

The company said it will begin shipping the product immediately.