Flonase Approved by FDA for OTC Use in U.S.

GlaxoSmithKline announced on Friday that the U.S. Food and Drug Administration has approved its over the counter allergy medication Flonase Allergy Relief, that gives temporary relief of upper respiratory allergies or hay fever symptoms.

The treatment is the first and only nasal spray that is over the counter and indicated as a relief for all nasal and eye-related allergy symptoms, including runny nose, itchy nose, sneezing, nasal congestion and watery and itchy eyes.

Flonase will be available at the full prescription strength as well as providing 24-hour allergy relief that is non-drowsy.

As many as 50 million people living in the U.S. suffer from some type of nasal allergies that take a big toll on those who have them.

Nasal allergies can cause fatigue, attention and learning problems, sleep disturbances as well as impair function at school or work.

In 2010, people in the U.S. with allergic rhinitis spent more than $17.5 billion on costs related to healthcare, lost over 6 million school and work days and visited doctors over 16 million times.

Flonase nasal spray is able to relieve inflammation providing relief of symptoms for up to 24 hours.

Fluticasone propionate which is Flonase’s active ingredient has helped allergy suffers more than any other form of nasal spray and contains a safety profile that is well established with over 30 million patient years since its first approval in 1994 as a prescription medication.

With Flonase being approved over the counter will make it easier to purchase, as it will not require any prescription. However, it will contain all the same levels of active ingredients as the prescription form that has been available for more than 20 years.

One difference is that the version only received through prescription focuses on nasal allergies and not ones that are ocular.

Flonase, said a GSK spokesperson, will be in drug stores and supermarkets throughout the U.S. by the early part of 2015.

Flonase sales have been projected by analysts to reach $105.6 million for fiscal year 2014, which is only 0.4% of the total revenues at GSK.



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