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August 6, 2014
Flonase Expected to Be Available in Early 2015

Parsippany, NJ—New on pharmacy shelves early next year: OTC fluticasone propionate 50-mcg spray.

GlaxoSmithKline (GSK) announced recently that the FDA had approved Flonase Allergy Relief as an OTC treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies. The formulation contains the most commonly prescribed allergy treatment ingredient, according to the company.

Flonase is the first and only OTC nasal spray indicated for relief of all nasal and eye-related allergy symptoms, including runny nose, sneezing, itchy nose, and nasal congestion as well as itchy and watery eyes, according to its manufacturer. The OTC product, formulated to provide 24-hour nondrowsy allergy relief, will be available at full-prescription strength, beginning in early 2015.

The GSK press release noted that about 50 million people in the United States suffer from nasal allergies, and that fluticasone propionate “has a well-established safety profile with 30 million accumulated patient years since it was first approved as a prescription medicine in 1994.”

“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,” explained Colin Mackenzie, GSK’s president of Consumer Healthcare North America.

“This approval will bring Flonase Allergy Relief to consumers in a convenient way at the same dosage strength as found in prescription Flonase,” added Vidhu Bansal-Dev, vice president for research and development. “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.”



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