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FDA approves Flonase for over the counter sales

GlaxoSmithKline has announced that the FDA has approved its Flonase fluticasone propionate nasal spray for the treatment of allergic rhinitis for over-the-counter sale. The approval is for a 50 mcg spray, the same as the current prescription strength. According to GSK, Flonase Allergy Relief will be available over the counter in the US in early 2015.

GSK President of Consumer Healthcare North America Colin Mackenzie commented, “With the significant number of allergy sufferers in the United States and a considerable number of those unsatisfied with their current treatments, we believe the wide availability of Flonase Allergy Relief over-the-counter is great news for these individuals. GSK has a strong heritage—40 years— in discovering and developing respiratory treatments used by patients worldwide. We are proud of our track record of successful Rx-to-OTC switches which over the years have significantly improved access to important medicines for our consumers.”

VP, Research and Development Vidhu Bansal-Dev added, “This approval will bring Flonase Allergy Relief to consumers in a convenient way at the same dosage strength as found in prescription Flonase. For those with allergies, being able to find simple, effective relief over the counter may mean the difference between a day lost to allergies and a day enjoying their favorite activities.”

The FDA approved Sanofi’s Nasacort Allergy 24HR triamcinolone acetonide nasal spray for OTC sales in October 2013, and that product was launched in February 2014.

Read the GSK press release.

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published on July 24, 2014

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