You are here

FDA Approves Generic Version of Flexeril

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.

Recent Headlines

Scenesse is new treatment for people with rare, painful light sensitivity disease
Humira, Rituxan top list of drugs that added $5.1 billion to nation's health care bill
Lower court rulings cleared the way for generic versions of the MS drug
Maryland man wins lawsuit that alleges that the company's antipsychotic caused his gynecomastia
Antidepressants, ADHD meds are also used to self-poison
Study lists steps that could save close to $300 billion a year
While many victims used THC, the cause remains elusive
Descovy joins Truvada, another Gilead product, in the HIV prophylaxis market
Data show PTC Therapeutics drug preserves lung function