FDA Approves Mylan Asthma Drug Generic Version of GlaxoSmithKline Advair Diskus

   By Josh Beckerman

The U.S. Food and Drug Administration approved a Mylan NV (MYL) drug that the agency said is the first generic of GlaxoSmithKline's (GSK) Advair Diskus.

Mylan obtained approval to market an inhaler in three strengths.

"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," the FDA said.

In 2013, the FDA issued guidance about the scientific studies that would be needed for approval of a generic version of Advair. Even with the expiration of patents, some analysts at that time expected the complexity of producing an exact copy could delay generics.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

January 30, 2019 20:08 ET (01:08 GMT)

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