Mylan Launching Generic Advair in Second Half of February
31 Enero 2019 - 3:15PM
Noticias Dow Jones
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)
Copyright (c) 2019 Dow Jones & Company, Inc.
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