Oct 7 2010
Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Losartan Potassium Tablets USP, 25mg, 50mg and 100mg as well as Losartan Potassium and Hydrochlorothiazide Tablets, 50mg/12.5mg and 100mg/25mg by the U.S. Food and Drug Administration. Both products are available for immediate shipment to wholesalers and pharmacies nationwide.
Roxane Laboratories' Losartan Potassium Tablets USP are AB rated to COZAAR® (losartan potassium) tablets while Losartan Potassium and Hydrochlorothiazide Tablets are AB rated to HYZAAR® (losartan potassium and hydrochlorothiazide) tablets. Annual sales of COZAAR® are approximately $940.2 Million while annual sales of HYZAAR® are approximately $670.7 Million.
SOURCE Roxane Laboratories, Inc.