U.S. Food and Drug administration (USFDA)has approved the first generic version of the Lipitor i.e. Cholesterol lowering drug by an Gurgaon-based Indian firm – Ranbaxy Laboratories Ltd. Lipitor was the patent of Pfizer Inc.
This approval by the United States health regulator will help the firm to launch the drug in American market.
U.S. Food and Drug Administration said in a statement,
Ranbaxy Laboratories Ltd has gained approval to make generic atorvastatin calcium tablets in 10 milligram, 20 mg, 40 mg, and 80 mg strengths. The drug will be manufactured by Ohm Laboratories in New Brunswick, NJ.
Ranbaxy will be one of the two companies with the approval to sell generic Lipitor for six months after expiration of its U.S. patents on Tuesday. While Watson Pharmaceuticals Inc. that is based in U.S. doesn’t need regulatory approval and has been authorized by Pfizer to sell generic version of Lipitor from November 30.
Ranbaxy and Pfizer had established all of their litigations globally over the patent in the year 2008.
“This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We are working very hard to get generic drugs to people as soon as the law will allow.”