Mylan Announces Final FDA Approval for Albuterol Sulfate Extended-Release Tablets
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- Published on Wednesday, 31 January 2007 02:00
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PITTSBURGH, PA, USA | Jan 30, 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 Albuterol Sulfate Extended-release (ER) Tablets, 4mg (base) and 8mg (base).
Albuterol Sulfate ER Tablets are the generic version of Dava Pharmaceutical's VoSpire ER(R), which had U.S. sales of approximately $19 million for the same strengths in the 12-month period ending Sept. 30, 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.