US regulator approves Flonase Allergy Relief for over-the-counter sales in US

Published: 25-Jul-2014
Regulatory Pharmaceutical

For temporary relief of hay fever and upper respiratory tract allergies


The US Food and Drug Administration (FDA) has given the green light to the sale of GlaxoSmithKline's Flonase Allergy Relief (fluticasone propionate 50mcg spray), as an over-the-counter (OTC) treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies.

The OTC product will be available early next year.

GSK says Flonase Allergy Relief is the first and only OTC nasal spray indicated for the relief of all nasal and eye-related allergy symptoms including runny nose, sneezing, itchy nose, nasal congestion and itchy and watery eyes. The product will be available at full prescription strength and provide 24-hour non-drowsy allergy relief.

Roughly 50 million people in the US suffer from nasal allergies, which can lead to fatigue, sleep disturbances, learning and attention problems and impaired function at work and/or school.

Flonase Allergy Relief was first approved as a prescription medicine in 1994.

  • Companies:
  • GlaxoSmithKline
  • US Food and Drug Administration (FDA)
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