Mylan Laboratories Inc. has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for propranolol hydrochloride Extended-Release (ER) capsules, USP in 60mg, 80mg, 120mg and 160mg strengths.
Propranolol hydrochloride ER capsules are the generic version of Wyeth Pharmaceutical's Inderal LA, which had US sales of approximately $201 million for the same strengths for the 12-month period ended Dec. 31, 2006, according to IMS Health.
This product will be shipped immediately, a company press release stated.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.