Mylan Laboratories Inc. has announced that Mylan Pharmaceuticals Inc. has received final approval from the 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. has three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc. Mylan develops, licenses, manufactures, markets and distributes a line of generic and proprietary products.
