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Mylan Announces FDA Approval for Cyclobenzaprine Hydrochloride Tablets USP, 5 mg |
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07 Feb 2006 |
PITTSBURGH, PA | Feb 06, 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 supplemental Abbreviated New Drug Application (ANDA) for Cyclobenzaprine Hydrochloride Tablets USP, 5 mg. Cyclobenzaprine Tablets are the AB-rated generic equivalent of McNeil's Flexeril® Tablets. U.S. sales for the 5 mg strength of Flexeril® were approximately $93 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. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.
For more information about Mylan, visit http://www.mylan.com/.
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SOURCE: Mylan Laboratories Inc.
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