FDA Approval of Expanded ProAir RespiClick Indication
April 28, 2016 – The U.S. Food and Drug Administration (FDA) approved an expanded indication for ProAir® RespiClick (albuterol sulfate) inhalation powder, manufactured by Teva. ProAir RespiClick is for the treatment and prevention of bronchospasms in children 4 to 11 years old with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasms. In March 2015, ProAir RespiClick was approved with the same indications for patients at least 12 years of 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 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.