FDA Rejects Perrigo's ProAir Generic, Drug Maker Says
May 11 2018 - 5:28PM
Dow Jones News
By Maria Armental
U.S. health regulators have rejected Perrigo Co.'s (PRGO)
generic version of Teva Pharmaceutical Industries Ltd.'s ProAir
inhalation aerosol, Perrigo said Friday.
Perrigo, which had targeted releasing the generic in the fourth
quarter and had built a roughly 9-cent-a-share projected benefit to
its 2018 financial forecast, said it had a teleconference call with
the Food and Drug Administration late Thursday afternoon and that
it expects to receive what is known as a complete response letter,
detailing the reasons for the rejection.
Over all, Perrigo had projected annual profit of $2.90 to $3.30
a share and $5.05 to $5.45 a share on an adjusted basis.
Perrigo's stock fell 4% to $74.10 in after-hours trading while
Teva's was down slightly at $19.30.
Write to Maria Armental at maria.armental@wsj.com
(END) Dow Jones Newswires
May 11, 2018 17:13 ET (21:13 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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