Supplier News Breaks Archives
Flonase allergy nasal spray set to go OTC
July 25th, 2014
PARSIPPANY, N.J. – GlaxoSmithKline's Flonase Allergy Relief nasal spray is slated to go over the counter starting next year.
GSK said Thursday that the Food and Drug Administration approved Flonase Allergy Relief spray (fluticasone propionate 50 mcg) as an OTC treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies.
The company noted that the product contains the No. 1 prescribed allergy treatment ingredient and is the first and only nonprescription 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.
Plans call for Flonase Allergy Relief to become available over the counter in early 2015. GSK said the spray will be available at full prescription strength and provide 24-hour, nondrowsy allergy relief.
"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," Colin Mackenzie, president of GSK Consumer Healthcare North America, said in a statement. "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."
About 50 million people in the United States suffer from nasal allergies, GSK reported. The company also cited research finding that 70% of sufferers treat their symptoms with prescription or OTC treatments, yet just 50% say they're satisfied with their current method of treatment.
"This approval will bring Flonase Allergy Relief to consumers in a convenient way at the same dosage strength as found in prescription Flonase," stated Vidhu Bansal-Dev, vice president of research and development at GSK. "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."