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US FDA approves fluticasone propionate nasal spray
Maryland | Friday, February 24, 2006, 08:00 Hrs  [IST]

The US Food and Drug Administration (FDA) approved fluticasone propionate nasal spray, the first generic version of the brand name drug Flonase, giving American consumers an additional, lower cost alternative when choosing prescription drug products. Fluticasone propionate nasal spray is manufactured by Roxane Laboratories of Columbus OH.

"Except for their price, which is much lower, generic drugs are in every way equivalent to their brand name counterparts. Offering consumers a choice of safe, effective, and reasonably priced generic drug products is an extremely important priority for FDA. Today's approval is part of our ongoing commitment to provide generic forms of products to the public," said Dr. Steven Galson, director of FDA's Centre for Drug Evaluation and Research.

Fluticasone propionate nasal spray treats the nasal symptoms of seasonal and chronic (long-lasting) allergic and non-allergic rhinitis, an inflammation of the lining of the nose that can make it stuffy and runny. This product is approved for use in both adults and children 4 years and older, informs a FDA release.

Fluticasone propionate nasal spray contains a synthetic, trifluorinated corticosteroid with anti-inflammatory activity. Corticosteroids are natural substances found in the body that help fight inflammation. Fluticasone propionate, like other corticosteroids, does not have an immediate effect on allergic symptoms. A decrease in nasal symptoms (stuffiness, runniness, itching, and sneezing) has been noted in some patients 12 hours after initial treatment. Common side effects of fluticasone propionate nasal spray are headache, sore throat and nose bleed.

The brand name product or innovator drug for fluticasone propionate is Flonase, manufactured by GlaxoSmithKline and approved in October, 1994. The drug's patent, including the paediatric exclusivity, expired in May 2004 and the new dosing schedule exclusivity with its associated paediatric exclusivity expired on November 23, 2005.

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