FDA Approves Flonase® Allergy Relief For Sale Over-The-Counter In The United States

PARSIPPANY, N.J., July 24, 2014 /PRNewswire/ -- GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Flonase® Allergy Relief (fluticasone propionate 50 mcg spray), containing the No. 1  prescribed allergy treatment ingredient¹, as an over-the-counter (OTC) treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies.²

Flonase® Allergy Relief is the first and only over-the-counter nasal spray indicated for relief of all nasal and eye-related allergy symptoms^3,4 including runny nose, sneezing, itchy nose^5-7, nasal congestion^8-11 and itchy and watery eyes.^12-15 Flonase® Allergy Relief will be available at full prescription strength and to provide 24-hour non-drowsy allergy relief.

Roughly 50 million people in the United States suffer from nasal allergies¹⁶, and allergies take a toll on sufferers:

• Nasal allergies can lead to fatigue, sleep disturbances, learning and attention problems and impaired function at work and/or school.¹⁷
• In 2010, Americans with allergic rhinitis (AR) spent approximately $17.5 billion on health- related costs, lost more than 6 million work and school days and made more than 16 million visits to the doctor.¹⁸
• 70 percent of sufferers treat their symptoms with prescription or OTC treatments¹⁹; however, 50 percent of them report they are not completely satisfied with their current method of treatment.²⁰

No other intra-nasal hay fever and allergy treatment has been proven more effective than Flonase® Allergy Relief,^1,8 a once-a-day nasal spray which helps relieve inflammation to provide 24-hour non-drowsy symptom relief.^21,22 Fluticasone propionate, the active ingredient in Flonase® Allergy Relief, has helped more allergy sufferers than any other nasal spray and has a well-established safety profile with 30 million accumulated patient years since it was first approved as a prescription medicine in 1994.²³

Colin Mackenzie, President, Consumer Healthcare North America, GSK, said, "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 products 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."

"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," said Dr. Vidhu Bansal-Dev, Vice President, Research and Development, GSK.

Flonase® Allergy Relief will be available over-the-counter in early 2015.

To learn more, visit www.Flonase.com for information and to sign up for allergy updates, allergy tips and special savings.

About Allergies

Symptoms of nasal allergies (allergic rhinitis) include sneezing, congestion, runny nose; itchy or sore throat, post-nasal drip and cough; and red, itchy watery eyes.²⁴ Allergy symptoms can leave sufferers feeling irritable, breathless, sleepless and fatigued.^25,26

About Flonase Allergy Relief

Flonase® Allergy Relief (fluticasone propionate 50 mcg spray) is an approved over-the-counter (OTC) treatment for hay fever symptoms including nasal congestion, runny nose, sneezing, itchy nose and itchy, watery eyes.

About GlaxoSmithKline Consumer Healthcare

GlaxoSmithKline Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its more than 30 well-known brands include the leading smoking cessation products, Nicorette® and NicoDerm®CQ®, as well as many medicine cabinet staples -- Aquafresh®, Sensodyne®, and TUMS® – which are trademarks owned by and/or licensed to GlaxoSmithKline Group of Companies.

About GlaxoSmithKline

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: http://www.gsk.com.

References

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2. Statement of fact
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5. Nathan RA, Bronsky EA, Fireman P, Grossman J et al. Once Daily Fluticasone Propionate Aqueous Nasal Spray Is an Effective Treatment for Seasonal Allergic Rhinitis. Annals of Allergy. 1991; 67(3): 332-338.
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SOURCE GlaxoSmithKline plc