Mylan: FDA approves cyclobenzaprine hydrochloride, generic of Flexeril

By E. Janene Geiss

Philadelphia, Feb. 6 - Mylan Laboratories Inc. announced Monday that Mylan Pharmaceuticals Inc. has received final approval from the Food and Drug Administration for its supplemental abbreviated New Drug Application for cyclobenzaprine hydrochloride tablets, 5 mg.

Cyclobenzaprine is the AB-rated generic equivalent of McNeil's muscle-relaxer Flexeril.

U.S. sales for the 5 mg strength of Flexeril were about $93 million for the 12-month period ended June 30, 2005, according to IMS Health.

The product will begin shipping immediately, Mylan said in a company news release.

Mylan is a Canonsburg, Pa., pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. Mylan develops, licenses, manufactures, markets and distributes generic and proprietary products.

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