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Mylan Announces Final FDA Approval for Propranolol Hydrochloride Extended-Release Capsules, USP |
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17 Feb 2007 |
Announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. 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.
PITTSBURGH, PA, USA | Feb 16, 2007 | Mylan Laboratories Inc. (NYSE: MYL) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. 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(R) LA, which had U.S. 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.
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.
For more information about Mylan, please visit www.mylan.com.
SOURCE Mylan Laboratories Inc |
