FDA Approves First Generic Version of Advair for Asthma, COPD
THURSDAY, Jan. 31, 2019 — The first generic form of the Advair Diskus (fluticasone propionate and salmeterol inhalation powder) inhaler has been approved by the U.S. Food and Drug Administration.
The medication can now be used to treat children aged 4 years and older with asthma and adults with asthma or chronic obstructive pulmonary disease (COPD). The generic inhaler is available 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.
The most common side effects from the inhaler’s use in patients with asthma include upper-respiratory tract infection, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headaches, nausea, and vomiting. For the treatment of COPD, the most common side effects are pneumonia, throat irritation, oral candidiasis, dysphonia, viral respiratory infection, headaches, and musculoskeletal pain.
“Today’s approval of the first generic drug product for one of the most commonly prescribed asthma and COPD inhalers in the U.S. is part of our longstanding commitment to advance access to lower cost, high quality generic alternatives,” Janet Woodcock, M.D., director of the FDA Center for Drug Evaluation and Research, said in a statement. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”
Approval of the generic Advair Diskus was given to Mylan, based in Canonsburg, Pennsylvania. The brand-name drug/device is produced by GlaxoSmithKline.
Posted: January 2019
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