Editorial Contact for Roxane Laboratories
- Phone (614) 272-4774
COLUMBUS, OH – October 15, 2012 – Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Applications (ANDA’s) for Irbesartan Tablets, USP and Irbesartan and Hydrochlorothiazide Tablets, USP by the U.S. Food and Drug Administration (FDA). Both products are available in bottles of 30 tablets and bottles of 90 tablets for immediate shipment to wholesalers and pharmacies nationwide.
Roxane Laboratories’ Irbesartan Tablets, USP are AB rated to AVAPRO® (irbesartan) tablets while Irbesartan and Hydrochlorothiazide Tablets, USP are AB rated to AVALIDE® (irbesartan and hydrochlorothiazide) tablets. Annual sales of AVAPRO® are approximately $351.1 Million1 with annual sales of AVALIDE® being approximately $102.2Million1.
Full prescribing information for Irbesartan Tablets, USP and Irbesartan and Hydrochlorothiazide Tablets, USP is available on the Roxane Laboratories website at www.RLI-TouchPoint.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 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.
For more information, please visit http://us.boehringer-ingelheim.com.
1IMS MAT dollar sales ending 6/2012
AVAPRO® and AVALIDE® are registered trademarks of the Bristol-Myers Squibb Company