COLUMBUS, Ohio, July 29 Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Risperidone Oral Solution, 1mg/mL by the U.S. Food and Drug Administration. The product is available in 30mL bottles for immediate shipment to wholesalers and pharmacies nationwide.
Roxane Laboratories' Risperidone Oral Solution, 1mg/mL are AA rated to RISPERDAL(R) (risperidone) oral solution. Annual sales of Risperidone Oral Solution, 1mg/mL are approximately $69.6 Million(1).
Full prescribing information for Risperidone Oral Solution, 1mg/mL 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 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 135 affiliates in 47 countries and approximately 39,800 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 2007, Boehringer Ingelheim posted net sales of US $15.0 billion (10.9 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 3/2009
RISPERDAL(R) is a registered trademark of Ortho-McNeil-Janssen Pharmaceuticals, Inc..
SOURCE Roxane Laboratories, Inc.