Mylan Launching Generic Advair in Second Half of February

   By Josh Beckerman

Mylan NV (MYL) will launch its Wixela Inhub, a generic version of GlaxoSmithKline PLC's blockbuster respiratory drug Advair Diskus, in the second half of February.

On Wednesday, the U.S. Food and Drug Administration said it approved the drug for certain patients with asthma or chronic obstructive pulmonary disease. The drug will be contained in an inhaler produced by Consort Medical (CSRT.LN).

GlaxoSmithKline previously warned that a generic version of Advair would hurt its results. Even after Advair's patents expired, the complexities of the drug have stalled competitors.

Mylan itself previously had been rejected, and Hikma Pharmaceuticals PLC (HKMPY) and Novartis AG (NVS) also have faced FDA-related setbacks.

Mylan said Thursday that the latest safety information required by the FDA prompted an amendment to the label for certain inhaled corticosteroids.

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

(END) Dow Jones Newswires

January 31, 2019 16:00 ET (21:00 GMT)

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