Arnuity Ellipta Receives Expanded Indication
May 22, 2018 – The U.S. FDA has approved an expanded indication for Arnuity® Ellipta® (fluticasone furoate inhalation powder), manufactured by GlaxoSmithKline. It is now approved to provide once-daily management therapy for children at least five years of age who have asthma.
The expanded indication was granted based on a clinical study that verified the safety and efficacy of Arnuity Ellipta in children ages 5 to 11 years. Children treated with Arnuity Ellipta showed improvement in baseline morning peak expiratory flow (PEF) compared to those who received a placebo.
Arnuity Ellipta should not be used as a rescue inhaler, or by patients with severe hypersensitivity to milk proteins or other ingredients found in the product. Recommended dosing is based on the patient’s age.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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.