Pharmaceutical Business review

GSK’s over-the-counter spray Flonase gets FDA approval

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, nasal congestion and itchy and watery eyes.

The spray will be available at full prescription strength and provides 24-hour non-drowsy allergy relief.

GSK North America Consumer Healthcare president Colin Mackenzie 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."

The company said that no other intra-nasal hay fever and allergy treatment has been proven more effective than Flonase Allergy Relief, a once-a-day nasal spray which helps relieve inflammation to provide 24-hour non-drowsy symptom relief.

FlonaseAllergy Relief’s active ingredient fluticasone propionate has helped more allergy sufferers than any other nasal spray.

GSK Research and Development vice-president Vidhu Bansal-Dev said the FDA 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," Bansal-Dev said.

According to the company, Flonase Allergy Relief will be available over-the-counter in early 2015.