COLUMBUS, Ohio, July 9 /PRNewswire/ -- Roxane Laboratories, Inc. announced today 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.
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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.
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 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.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and approximately 38,400 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 2006, Boehringer Ingelheim posted net sales of US $13.3 billion (10.6 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 April 2007
NORVASC(R) is a registered trademark of Pfizer Inc.
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CONTACT: Jason Kurtz, for Roxane Laboratories, +1-440-201-3668, orjkurtz@cle.boehringer-ingelheim.com
