Mylan Pharmaceuticals Inc. has received final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for bisoprolol fumarate tablets USP, 5mg and 10mg, states a company release.
Bisoprolol fumarate tablets, which are the AB-rated generic version of Duramed Pharmaceuticals' Zebeta tablets, 5mg and 10 mg, had US sales of approximately $27 million, for the 12-month period ended June 30, 2005, according to IMS Health.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. that develop, license, manufacture, market and distribute an extensive line of generic and proprietary products.