FDA Rejects Mylan's Asthma Generic Over Deficiencies -- Market Mover
June 13 2018 - 8:31PM
Dow Jones News
Mylan NV's (MYL) shares fall 5% to $39.65 in after-hours trading
Wednesday after the drugmaker says in a regulatory filing that U.S.
health regulators have found "minor deficiencies" in its proposed
generic version of GlaxoSmithKline PLC's asthma blockbuster Advair.
The Food & Drug Administration is to send Mylan the rejection
notice, called a complete response letter, on June 27. Mylan, which
didn't offer any details on the deficiencies found, said it would
then determine if it needs to adjust its 2018 forecast.
(maria.armental@wsj.com; @mjarmental)
(END) Dow Jones Newswires
June 13, 2018 20:16 ET (00:16 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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