Competitors to Advair Launched
April 20, 2017 - AirDuo™ RespiClick®, a dry-powder inhaler that combines fluticasone propionate and salmeterol was launched by Teva. At the same time, Teva also released its authorized generic to AirDuo RespiClick. AirDuo RespiClick as well as the authorized generic are indicated for the maintenance treatment of asthma in patients who are 12 years of age or older. Recommended dosing is one inhalation two times a day. While both products contain the same active components as Advair® (fluticasone propionate and salmeterol) manufactured by GlaxoSmithKline, neither product is A-rated or directly substitutable with Advair.
As for a direct generic to Advair, Mylan and Hikma/Vectura both have generic products under review. Mylan received a complete response letter for its proposed generic to GlaxoSmithKline’s Advair Diskus® (fluticasone propionate and salmeterol) in March. Meanwhile a generic from Hikma/Vectura is under review with a GDUFA date of May 10, 2017, that FDA is not expected to approve its generic at that time. True generics to Advair Diskus could reach the market sometime in 2018.
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.