COLUMBUS, Ohio, July 2 /PRNewswire/ -- Roxane Laboratories, Inc. announced today that they received approval for its Abbreviated New Drug Application (ANDA) for Terbinafine Hydrochloride Tablets, 250mg by the U.S. Food and Drug Administration. The product is available in bottles of 30 tablets and 100 tablets for immediate shipment to wholesalers and pharmacies nationwide.
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Roxane Laboratories’ Terbinafine Hydrochloride Tablets, 250mg are AB rated to LAMISIL(R) (terbinafine hydrochloride). Annual sales of Terbinafine Hydrochloride Tablets, 250mg are approximately $687 Million(1).
Full prescribing information for Terbinafine Hydrochloride Tablets, 250mg 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 03/2007
LAMISIL(R) is a registered trademark of Novartis Pharmaceuticals Corporation
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CONTACT: Jason Kurtz, Roxane Laboratories, +1-440-201-3668, orjkurtz@cle.boehringer-ingelheim.com
