FDA Approves Flonase Sensimist Allergy Relief

Article Link: FDA Approves Flonase Sensimist Allergy Relief

FDA Approves Flonase Sensimist Allergy Relief

WARREN, N.J. 2 August 2016 — GSK Consumer Healthcare announced today that the U.S. Food and Drug Administration (FDA) has approved Flonase® Sensimist™ Allergy Relief (fluticasone furoate, 27.5 mcg spray) as an over-the-counter (OTC) treatment for symptoms associated with seasonal and perennial allergies. Previously available by prescription as Veramyst®, Flonase Sensimist is the latest Rx-to-OTC switch from GSK.

Flonase Sensimist helps block six allergic substances*, providing non-drowsy, 24-hour relief of both nose- and eye-related allergy symptoms like itchy, watery eyes**, nasal congestion, runny nose, itchy nose and sneezing.

“There are roughly 50 million people in the United States who suffer from allergies,2 and, as a category leader, GSK continues to innovate to satisfy the needs of all allergy sufferers,” said Amardeep Kahlon, Director of Marketing. “In the case of Flonase Sensimist, GSK is proud to offer an additional treatment option that not only provides more complete allergy symptom relief1 but also suits specific consumer preferences.”

Additional key features of Flonase Sensimist include:

  • Nasal allergy relief indicated for adults and children ages 2 and older**
  • Scent-free
  • Alcohol-free
  • Little or no drip

Flonase Sensimist will be nationally available OTC in early 2017.

About Flonase Sensimist

Flonase Sensimist (fluticasone furoate, 27.5 mcg spray) is an approved over-the-counter treatment for symptoms associated with seasonal and perennial allergic rhinitis including sneezing, runny nose, itchy nose, congestion, and itchy, watery eyes.**

About GSK Consumer Healthcare

GSK Consumer Healthcare is one of the world’s largest consumer healthcare companies. Our purpose is to help more people around the world to do more, feel better and live longer with everyday healthcare products. We have a heritage that goes back over 160 years. We own some of the world’s best loved healthcare brands, including Sensodyne®, Theraflu®, Excedrin®, Nicorette® and NicoDerm®CQ®, Flonase®, and TUMS®. These brands are successful in over 100 countries around the world because they all show our passion for quality, guaranteed by science. They are inspired by the real wants and needs of the millions of people who walk into pharmacies, supermarkets, market stalls and go on-line all over the world every day, and choose us first.

Our goal is to build a global, growing business we call a Fast Moving Consumer Healthcare (FMCH) company, dedicated to everyday healthcare with all of the scientific expertise and quality guarantees that demands, working at the speed and with the genuine consumer understanding the modern world expects.

About GSK

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.

* Flonase Sensimist Allergy Relief acts on multiple inflammatory substances (histamine, prostaglandins, cytokines, tryptases, chemokines and leukotrienes). The exact number and precise mechanism are unknown.
** Indication for “itchy, watery eyes” for ages 12 years and older.


1 vs. single-ingredient antihistamines which do not treat nasal congestion
2Allergy Facts and Figures. Asthma and Allergy Foundation of America. (July 2016) Retrieved from http://www.aafa.org/page/allergy-facts.aspx.

Source: GSK

Posted: August 2016

Flonase Sensimist (fluticasone furoate) FDA Approval History

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Source: FDA New Drug Approvals