Veramyst Marketing Status Changed to Over-the-Counter
August 2, 2016 – The FDA approved GlaxoSmithKline’s request to change the marketing status of Veramyst® (fluticasone furoate, 27.5mcg) from prescription-only to over-the-counter (OTC). The OTC version will have a new brand name, Flonase® Sensimist™ Allergy Relief. Flonase Sensimist is labeled to treat nasal congestion, sneezing and runny nose from both seasonal and perennial allergies for patients age two and older. Patients who are at least 12 years old also can use it to manage itching, watering eyes caused by allergies. Plans are to introduce Flonase Sensimist well before the 2017 spring allergy season. Flonase® Allergy Relief Spray (fluticasone propionate, 50mcg) has been an OTC product since early 2015.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.