COLUMBUS, Ohio, July 8 /PRNewswire/ -- Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Naratriptan Tablets USP, 1mg and 2.5mg by the U.S. Food and Drug Administration. The product is available in bottles of 9 for immediate shipment to wholesalers and pharmacies nationwide.
Roxane Laboratories' Naratriptan Tablets USP are AB rated to AMERGE® (naratriptan hydrochloride) tablets. Annual sales of AMERGE® are approximately $60.2 Million(1). AMERGE® Tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.
Full prescribing information for Naratriptan Tablets USP is available on the Roxane Laboratories website at www.Roxane.com or upon request by calling Roxane Laboratories Technical Product Information at
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 142 affiliates in 50 countries and more than 41,500 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 2009, Boehringer Ingelheim posted net sales of US $17.7 billion (12.7 billion euro) while spending 21% of net sales in its largest business segment, Prescription Medicines, on research and development.
For more information, please visit http://us.boehringer-ingelheim.com.
(1) IMS MAT dollar sales ending 3/2010
AMERGE® is a registered trademark of GlaxoSmithKline
SOURCE Roxane Laboratories, Inc.