Allergies are second only to the weather in hot conversation topics around here in the Midwest. So, there was a collective groan when sales of generic Flonase were halted by a judge’s temporary restraining order. This comes two days after the U.S. Food and Drug Administration approved a generic nasal spray for the active ingredient fluticasone, the first generic version of the brand name drug Flonase.
The FDA’s approval of the Roxane Labs version was announced Feb. 20, GlaxoSmithKline filed a court motion Feb. 21 seeking to temporarily ban sales of generic Flonase based on two counts. Glaxo argued that the FDA had not established a method of proving the “bioequivalence” of the generic drugs to Flonase and said that the government agency had applied one set of quality standards to Flonase and a separate set to generic versions of the drug.
A district court judge granted a 10-day restraining order on Friday, blocking sales of the generic spray although Roxane Laboratories expects the restraining order would be lifted after a hearing on March 6. Since Glaxo has a deal with Par Pharmaceuticals to make an approved generic version of Flonase, the ruling stops Par’s product as well.
Fluticasone Propionate Nasal Spray treats the nasal symptoms of seasonal and chronic (long-lasting) allergic 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. Roxane Laboratories, based in Columbus, Ohio, will market the new drug.
The FDA’s statement regarding fluticasone emphasized that the generic drug is the “bioequivalent to a brand name drug and is its equal in dosing form, strength, route of administration, quality, performance characteristics and intended use.”
Given that Flonase brought in more than $920 million in U.S. sales in 2005, even a 10-day restraining order can mean a huge profit. We’ll keep you posted on the result.
