FDA Clears OTC Flonase Nasal Spray for Allergy Relief

Megan Brooks

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July 25, 2014

The US Food and Drug Administration (FDA) has approved over-the-counter (OTC) fluticasone propionate 50 mcg nasal spray (Flonase Allergy Relief, GlaxoSmithKline) for treatment of hay fever or upper respiratory allergies, the company announced yesterday.

Flonase Allergy Relief 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, nasal congestion, and itchy and watery eyes, according to a company news release.

An estimated 50 million people in the United States suffer from nasal allergies, often leading to fatigue, sleep disturbances, learning and attention problems, and impaired function at work and school, the company notes.

Fluticasone propionate, the active ingredient in Flonase Allergy Relief, has a "well-established safety profile with 30 million accumulated patient years since it was first approved as a prescription medicine in 1994," the company states.

Flonase Allergy Relief will be available OTC in early 2015, according to GlaxoSmithKline.

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