First Generic Version of Advair Diskus Approved 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.
It can now be used to treat children aged 4 or older with asthma and adults with asthma or chronic obstructive pulmonary disease (COPD).
"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, " said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
More than 26 million people in the United States have asthma, and about 7 million are children, the agency said in a news release. COPD is a chronic lung disease that triggers coughing, chest tightness and makes it hard to breathe. It may worsen over time, the FDA said.
The agency said it requires data showing that generic drug devices meet the agency's rigorous approval standards to ensure they are as safe and effective as their brand-name counterparts.
The most common side effects from the inhaler's use in asthmatics include upper-respiratory tract infection, swelling in the back of the throat, hoarse voice, bronchitis, cough, headaches, nausea and vomiting. For the treatment of COPD, the most common side effects are pneumonia, throat irritation, hoarse voice, viral respiratory infection, headaches and musculoskeletal pain.
Approval of the generic Advair Diskus was given to Mylan, based in Canonsburg, Pa. The brand-name drug/device is produced by GlaxoSmithKline.
Visit the U.S. National Heart, Lung, and Blood Institute for more on asthma.
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Posted: January 2019