COLUMBUS, Ohio, March 7 /PRNewswire/ -- Roxane Laboratories, Inc. today announced that on March 6, 2006, the district court of Maryland denied GlaxoSmithKline's request to further extend the order temporarily suspending the U.S. Food and Drug Administration's (FDA) approval of Roxane Laboratories' Fluticasone Propionate Nasal Spray, 50 mcg. Importantly, Roxane Laboratories has immediately resumed shipping product to wholesalers and pharmacies nationwide.
Following a full hearing on the merits of the case, 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. As a result of this court ruling, the FDA has lifted the temporary suspension of their approval of Roxane Laboratories' product.
Roxane Laboratories' Fluticasone Propionate Nasal Spray is AB rated to GlaxoSmithKline FLONASE(R) (fluticasone propionate) Nasal Spray. Annual sales of FLONASE(R) (fluticasone propionate) Nasal Spray are approximately $1.2 billion(1).
Roxane Laboratories, Inc., located in Columbus, OH, is a subsidiary of the Ridgefield, CT, based Boehringer Ingelheim Corporation, 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 144 affiliates in 45 countries and nearly 36,000 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 2004, Boehringer Ingelheim posted net sales of US $10.2 billion (8.2 billion euro) while spending nearly 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.
Full prescribing information for Fluticasone Propionate Nasal Spray is available on the Roxane web site at http://www.Roxane.com or upon request by calling Roxane Laboratories Technical Product Information at 1-800-962-8364.
(1)IMS MAT dollar sales ending December 2005
FLONASE(R) is a registered trademark of GlaxoSmithKline.
Roxane Laboratories, Inc.CONTACT: Dawn Plante, Communications & Public Relations of RoxaneLaboratories, Inc., +1-440-201-3487, Fax: +1-440-232-8751,dplante@cle.boehringer-ingelheim.com
