Teva gets tentative FDA OK for generic Lipitor

AP News
Posted: Dec 01, 2011 4:20 PM
Teva gets tentative FDA OK for generic Lipitor

The Food and Drug Administration has granted Teva Pharmaceuticals USA tentative approval to sell a generic version of Pfizer Inc.'s cholesterol blockbuster, Lipitor.

The agency says Teva's research data shows its pill is safe and effective.

The FDA cannot grant final approval until May 31. India's Ranbaxy Laboratories has the exclusive right to sell generic Lipitor, or atorvastatin, for 180 days after Lipitor's U.S. patent expired on Wednesday, because it was the first company to successfully challenge Lipitor's patent.

Ranbaxy began shipping its version after getting FDA approval late Wednesday. Watson Pharmaceuticals Inc. is selling an authorized generic under a partnership with Pfizer.

Teva USA is part of Israel's Teva Pharmaceutical Industries Ltd.