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.
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