FDA approves less-restrictive labeling for Valeant's Parkinson's disease drug Tasmar

By Lisa Kerner

Erie, Pa., Feb. 22 - Valeant Pharmaceuticals International said the Food and Drug Administration has approved less-restrictive labeling for Tasmar (tolcapone), the company's COMT (catechol-O-methyltransferase) inhibitor product for Parkinson's disease patients undergoing treatment with levodopa/carbidopa.

The new labeling calls for less frequent laboratory monitoring for patients taking the drug and allows patients to remain on Tasmar at higher ALT levels than previously required, according to a company news release.

Valeant presented to the FDA more than 40,000 patient years of worldwide Tasmar IMS prescription data and analysis results of more than 3,400 Tasmar-treated patients participating in clinical trials.

"To date, more than 365,000 Tasmar prescriptions have been written for Parkinson's disease patients undergoing treatment with levodopa/carbidopa, while more than 1.5 million Americans suffer from this debilitating disease," president and chief executive officer Timothy C. Tyson said in the release.

"The new labeling for Tasmar will allow physicians to prescribe the drug, which has been proven to be safe and effective, to more Parkinson's disease patients."

Valeant discovers, develops, manufactures and markets products primarily in the areas of neurology, infectious disease and dermatology. The company is based in Costa Mesa, Calif.

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