Flonase Allergy Relief Receives FDA Approval for OTC Sale in US

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GlaxoSmithKline announced that the U.S. Food and Drug Administration has approved Flonase Allergy Relief (fluticasone propionate 50 mcg spray) as an OTC (over-the-counter) treatment for temporary relief of the symptoms of upper respiratory allergies or hay fever.

Flonase Allergy Relief is the first and only over-the-counter nasal spray indicated for relief of all nasal and eye-related allergy symptoms which includes sneezing, runny nose, nasal congestion, itchy nose, and watery and itchy eyes. Flonase Allergy Relief will be available at full prescription strength to provide 24-hour non-drowsy allergy relief.

No other intra-nasal allergy and hay fever treatment has proven more effective than Flonase Allergy Relief, which is a once-a-day nasal spray which helps relieve inflammation to provide 24-hour non-drowsy symptom relief. The active ingredient in Flonase Allergy Relief, Fluticasone propionate, has helped more allergy sufferers than any other nasal spray and it has a well-established safety profile with 30 million patients since it was first approved as a prescription medicine in 1994.

President, Consumer Healthcare North America, GSK, Colin Mackenzie said that they believe the wide availability of Flonase Allergy Relief over-the-counter is great news for the significant number of allergy sufferers in the United States and a considerable number of those unsatisfied with their current treatments. According to Mackenzie, GSK has a strong legacy of over 40 years in discovering and developing respiratory products which are used by patients worldwide. He further stated that the company is proud of their track record of successful Rx-to-OTC conversions which over the years have considerably improved access to important medicines to consumers.

Vice President, Research and Development, GSK, Dr. Vidhu Bansal-Dev said that this approval by FDA will bring Flonase Allergy Relief to consumers at the same dosage strength as found in prescription Flonase. For people suffering from frequent and recurrent allergies, being able to find simple and effective relief over the counter will make a huge difference. Flonase Allergy Relief will be available over-the-counter in early 2015.