Rhinocort Approved for OTC Use
March 23, 2015 – The U.S. Food and Drug Administration (FDA) approved Rhinocort (budesonide) as an over the counter nasal spray for the temporary relief of symptoms of hay fever or other upper respiratory allergies (nasal congestion, runny nose, itchy nose, and sneezing) in adults and children ages 6 years and older. Rhinocort Allergy Spray will compete in the non-prescription market with Flonase Allergy Relief (fluticasone propionate) and Nasacort Allergy 24HR (triamcinolone acetonide - Chattem).
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 a 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.