Roxane Laboratories announces launch of Amlodipine Besylate tablets

Jul 10 2007

Roxane Laboratories, Inc. has announced the approval of its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate Tablets, 2.5mg, 5mg, and 10mg by the U.S. Food and Drug Administration.

The product is available in bottles of 90, and the 5mg and 10mg tablets are available in bottles of 300 and Unit Dose Blisters for immediate shipment to wholesalers and pharmacies nationwide.

Roxane Laboratories' Amlodipine Besylate Tablets, 2.5mg, 5mg, and 10mg are AB rated to NORVASC(R) (amlodipine besylate)Tablets. Annual sales of Amlodipine Besylate Tablets, 2.5mg, 5mg, and 10mg are approximately $2.7 Billion(1).

Full prescribing information for Amlodipine Besylate Tablets, 2.5mg, 5mg, and 10mg 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.

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 75 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.

http://us.boehringer-ingelheim.com/ .