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FDA Approves Generic Version of Flexeril
August 6, 2013
PITTSBURGH, Feb. 6 /PRNewswire-FirstCall/ -- 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(R) Tablets. U.S. sales for the 5 mg strength of Flexeril(R) were approximately $93 million for the 12-month period ending June 30, 2005, according to IMS Health.
This product will begin shipping immediately.
Source: Mylan Laboratories, Inc.
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