COLUMBUS, Ohio, Oct. 6 /PRNewswire/ -- 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(1) while annual sales of HYZAAR® are approximately $670.7 Million(1).
Full prescribing information for Losartan Potassium Tablets USP and Losartan Potassium and Hydrochlorothiazide Tablets is available on the Roxane Laboratories website at www.Roxane.com or upon request by calling Roxane Laboratories Technical Product Information at 1.800.962.8364.
About Roxane Laboratories, Inc.
Roxane Laboratories is located in Columbus, OH in a modern 500,000 square foot manufacturing and laboratory facility. The facility spans 70 acres and currently employs over 1,000 people. Currently, Roxane Laboratories markets over 80 medications in nearly 250 package sizes, focusing on an expanding line of Multisource pharmaceutical products including: bulk and unit-dose liquids and solids; coated, sustained-release and controlled-release tablets; nasal sprays, cytotoxics and CII narcotics.
Roxane Laboratories, Inc., is a subsidiary of Boehringer Ingelheim Corporation, based in Ridgefield, CT and a member of the Boehringer Ingelheim group of companies.
About Boehringer Ingelheim
Boehringer Ingelheim Corporation based in Ridgefield, CT, is the US headquarters to seven subsidiaries and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and approximately 41,300 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
For more information on Boehringer Ingelheim, please visit http://us.boehringer-ingelheim.com.
(1) IMS MAT dollar sales ending 6/2010
COZAAR® and HYZAAR® are registered trademarks of Merck & Co., Inc.
SOURCE Roxane Laboratories, Inc.