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Mylan Announces Final FDA Approval for Alprazolam Extended-release Tablets |
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27 Jan 2006 |
Pittsburgh. US | Jan. 27, 2006 | 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 Alprazolam Extended-release Tablets, 0.5 mg, 1 mg, 2 mg and 3 mg. Alprazolam Extended-release Tablets are the AB-rated generic equivalent of Pharmacia's and Upjohn's Xanax XR(R) Tablets, which had U.S. sales of approximately $100 million for the 12-month period ending June 30, 2005, according to IMS Health.
This product will begin shipping immediately.
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.
For more information about Mylan, visit www.mylan.com.
SOURCE: Mylan Laboratories |
