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FDA approves first generic of Advair Diskus® inhaler for asthma and COPD

by Mary McNitt | Feb 05, 2019

The U.S. Food and Drug Administration (FDA) has approved the first generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder). Mylan is the first company to obtain FDA approval to market its generic inhaler.

Advair Diskus, manufactured by GlaxoSmithKline, received its FDA approval in 2000. However, until now, the FDA declined to approve generic versions from several pharmaceutical companies.

Advair Diskus is considered a combination product containing two medications and a device for oral inhalation ― fluticasone, an inhaled corticosteroid (ICS) and salmeterol, a long-acting beta2-adrenergic agonist (LABA). It is commonly used to treat asthma in patients over four years of age, as well as maintenance treatment of airflow obstruction and to reduce exacerbations (flare-ups) in chronic obstructive pulmonary disease (COPD).

Advair Diskus is not for everyone and not first-line therapy for asthma or COPD. However, an ICS combined with a LABA has been shown to be more effective than the individual components in improving lung function, health status and reducing exacerbations in those patients with exacerbations and moderate to very severe COPD.

Availability and timing
Mylan has been approved to promote its generic inhaler, Wixela™ Inhub™, in three strengths: fluticasone propionate 100 mcg/salmeterol 50 mcg, fluticasone propionate 250 mcg/salmeterol 50 mcg and fluticasone propionate 500 mcg/salmeterol 50 mcg. Dosage should be based on the severity of the patient’s condition and administered as one inhalation twice a day.

Reports indicate that Mylan is expected to launch its generic version in February 2019, although the cost is unknown at this time. Generic medications are as safe and effective as their name-brand counterparts but offer cost savings to consumers. And while the dispensing of Advair Diskus is not routine for claims in workers’ compensation and auto-related injuries, it can occur. Currently, Advair Diskus and similar combination products are allowed on our standard respiratory formularies.

For more information on the FDA announcement, please click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

  1. U.S. Food and Drug Administration. News & Events. Newsroom. Press Announcements. FDA News Release. January 30, 2019. FDA approves first generic Advair Diskus. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630151.htm?utm_campaign=FDA/.
  2. Reuters. Health News. January 30, 2019. FDA approves Mylan’s generic of Advair asthma treatment. Available at: https://www.reuters.com/article/us-mylan-nl-fda/fda-approves-mylans-generic-of-advair-asthma-treatment-idUSKCN1PO2Z7.
  3. Mylan Press Release. Mylan Announces FDA Approval of Wixela™ Inhub™ (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder). January 31, 2019. Available at: http://newsroom.mylan.com/2019-01-31-Mylan-Announces-FDA-Approval-of-Wixela-TM-Inhub-TM-fluticasone-propionate-and-salmeterol-inhalation-powder-USP-First-Generic-of-ADVAIR-DISKUS-R-fluticasone-propionate-and-salmeterol-inhalation-powder.
  4. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 report. Available at: http://goldcopd.org/ .

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