FDA gives tentative approval for Watson generic cholesterol drug

Watson’s rosuvastatin zinc 5, 10, 20 and 40mg tablets are the generic version of Astrazeneca’s Crestor (rosuvastatin calcium) tablets.

Crestor is indicated, as an adjunct to diet, to lower LDL cholesterol, raise HDL cholesterol, and slow the progression of atherosclerosis.

Earlier on 26 October 2010, Astrazenaca sued Watson in the US Court for the District of Delaware to prevent Watson from commercializing the drug before the expiration of US patent no. RE 37,314.

Watson expects to get the final approval for rosuvastatin zinc tablets, which are a new salt form of Crestor tablets following the final settlement of the case.