Mylan Announces Final FDA Approval for Sotalol Hydrochloride Tablets, USP (AF)
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- Published on Friday, 09 February 2007 02:00
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PITTSBURGH, PA, USA | Feb 08, 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 Sotalol Hydrochloride Tablets USP (AF), 80mg, 120mg and 160mg.
Sotalol Hydrochloride Tablets USP (AF) are the generic version of Berlex Inc.'s Betapace AF(TM) Tablets, which had U.S. sales of approximately $10.5 million for the same strengths in the 12-month period ending 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.