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)
See more

You may also like

Regulatory

FDA's novel report on economically motivated adulteration in honey

Read more
3% of the 107 samples taken between April 2022 and July 2023 were found to be in violation of regulatory laws

Trending Articles

  1. Isospec launches analysis technology to identify unknown molecules The novel technology can facilitate the detection of trace amounts of unidentified molecules in nutraceutical formulations
  2. Mission C announces validation of two Sports Isolate oil drops "This accreditation marks a significant milestone in Mission C's commitment to providing high-quality and trusted wellness solutions to its valued customers"
  3. US Hemp Authority introduces 'adult use' hemp product certification The novel regulations attempt to curb the proliferation of hemp products that can impair users, such as delta-8 and delta-9 THC
  4. Biofarma acquires US Pharma Lab and focuses solely on nutraceuticals This partnership marks the evolution of Biofarma Group into the first global CDMO solely focused on nutraceuticals
  5. USP renews verified status for first and only saw palmetto for Valensa’s USPlus USPlus Saw Palmetto, which supports prostate health, successfully completes annual surveillance by USP’s Ingredient Verification Program for Dietary Ingredients, reflecting adherence to good manufacturing practices (GMPs) and recognised quality standards

Upcoming event

Vitafoods Europe

14–16 May 2024 | Exhibition | Palexpo, Geneva See all

You may also like

Regulatory

FDA's novel report on economically motivated adulteration in honey

3% of the 107 samples taken between April 2022 and July 2023 were found to be in violation of regulatory laws
Regulatory

FDA issues draft guidance on dietary ingredient notification master files

The updated guidance on dietary ingredients for supplementation purposes facilitates the submission of manufacturing and safety information
Ingredients

FDA sponsors workshops on meta-analyses in nutrition research and policy

The FDA will sponsor three workshops to discuss the usefulness of meta-analysis as a tool for nutrition research and developing nutrition policy
Ingredients

Gaia Herbs issues open letter to FDA highlighting transparency standards

The herbal supplement brand Gaia Herbs has issued an invite to the FDA to inspect and evaluate their practices and products
Regulatory

Fungi Perfecti issues response to Nammex FDA citizen petition

This joint letter comes in response to the opinion presented in the recent FDA Citizen Petition filed by Nammex, which obfuscates and misrepresents the use of well-established mycological
Ingredients

Nammex petitions FDA to clarify "mushroom" from "mycelium" ingredients

The Canada-based functional mushroom ingredient provider has submitted a citizen petition to the FDA asking the agency to clarify labelling requirements as many new companies enter the sector
Regulatory

CRN urges FDA to reconsider “food groups-only” approach

CRN’s comments to FDA emphasised the value of including dietary supplements and functional foods
Subscribe now