COLUMBUS, Ohio, April 10 /PRNewswire/ -- Roxane Laboratories, Inc. today announced that on April 6, 2007 the district court of Maryland ordered that the $3 million dollar bond posted by GlaxoSmithKline be released to Roxane. GSK was ordered to post the bond over a year ago when it filed a lawsuit against the FDA following the FDA’s approval of Roxane’s fluticasone propionate its generic equivalent to FLONASE(R)(1). Following a hearing on the merits of the lawsuit in March 2006, the district court found that the FDA’s approval process was well within the law, and that patients are entitled to the cost benefits of Roxane Laboratories’ safe and therapeutically equivalent generic fluticasone propionate nasal spray. The payment of the $3 million is the last step in this process and supports Roxane’s goal of offering this low-cost alternative to its customers.
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Roxane Laboratories worked in cooperation with the FDA to satisfy all guidelines to obtain approval for fluticasone propionate nasal spray. The patent for FLONASE(R) (fluticasone propionate) Nasal Spray expired May 14, 2004. Following a three year review period, the FDA approved Roxane’s ANDA application after determining Roxane’s generic fluticasone propionate is therapeutically equivalent to the branded drug. Roxane Laboratories satisfied all scientific and regulatory requirements and obtained approval from the FDA for a bioequivalent generic version of FLONASE(R) on February 22, 2006.
Roxane Laboratories’ fluticasone propionate nasal spray is AB rated to FLONASE(R) (fluticasone propionate) Nasal Spray and is available through all major wholesalers in the United States.
Roxane Laboratories
Roxane Laboratories, Inc. (Columbus, Ohio), is a subsidiary of Boehringer Ingelheim Corporation, based in Ridgefield, CT 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 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, please visit http://us.boehringer-ingelheim.com.
(1) FLONASE(R) is a registered trademark of GlaxoSmithKline Pharmaceuticals.
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CONTACT: Jason Kurtz of Roxane Laboratories, +1-440-201-3668
Web site: http://us.boehringer-ingelheim.com//
