FDA Approves First Generic Version of Flonase

FDA is Committed to Providing Generic Alternatives to American Consumers

The Food and Drug Administration (FDA) today 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.

"Except for their price, which is much lower, generic drugs are in every way equivalent to their brand name counterparts," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "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."

Generic drug products are used to fill over 50 percent of all prescriptions, and since they cost a fraction of the price of trade name drugs, the economic impact of FDA's generic drug program is profound. Through hard work, prioritization, and optimizing efficiencies, FDA's Office of Generic Drugs continues to make record numbers of generic products available. In 2005 alone, FDA approved 452 generic drug applications, the second highest total on record.

Fluticasone Propionate Nasal Spray treats the nasal symptoms of seasonal and chronic (long-lasting) allergic rhinitis and nonallergic 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.

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 pediatric exclusivity, expired in May 2004 and the new dosing schedule exclusivity with its associated pediatric exclusivity expired on November 23, 2005.

FDA received several citizen petitions questioning the approval criteria for the drug's bioequivalence and for other aspects of nasal sprays related to today's action. The FDA submits generic drug applications to the same thorough and rigorously scientific review for safety, effectiveness and quality as the applications for new drugs. Consumers and health professionals can be assured that an approved generic drug is bioequivalent to a brand name drug and is its equal in dosage form, strength, route of administration, quality, performance characteristics, and intended use.

After reviewing the issues raised in the petitions, FDA determined that its current standards for approval are appropriate.

Fluticasone propionate nasal spray is manufactured by Roxane Laboratories of Columbus, OH.

For additional information related to FDA's Office of Generic Drugs, please go to: http://www.fda.gov/cder/consumerinfo/generic_equivalence.htm.

Source: FDA Approves First Generic Version of Flonase

Posted: February 2006


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