Jan. 31 (UPI) — The U.S. Food and Drug Administration has approved the first generic form of a popular asthma inhaler, according to the agency.
Pharmaceutical company Mylan got approval to produce and market the combination fluticasone propionate and salmeterol drug at three strengths levels, the FDA announced Thursday.
After the announcement of its approval, Mylan’s stock price jumped by 7 percent.
“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, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. “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.”
Nearly 27 million Americans have asthma, according to the Centers for Disease Control and Prevention.
COPD is a progressive disease that attacks the lungs, causing shortness of breath, chest tightness and other symptoms. Roughly 11 million people in the U.S. have been diagnosed with COPD, the nation’s third leading cause of death.
“The FDA recognizes challenges companies face when seeking to develop hard-to-copy complex generics, such as drug-device combination products, including when the drugs are incorporated into inhalation devices like this,” said Anna Abram, Deputy Commissioner at the FDA.
“We are committed to advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many applications covering proposed generic complex products for which a generic has not yet been approved.”