June 30 Allergan Inc on Monday said the
U.S. Food and Drug Administration had raised issues about its
application for a new acute migraine treatment and that it was
working with the agency to address them.
Allergan, the Botox maker that is fighting off a hostile bid
from Valeant Pharmaceuticals International Inc, said it
had received a second "complete response letter" from the
agency. It now expects the next action from the FDA on Semprana,
formerly known as Levadex, to occur in the second quarter of
Sterne Agee analyst Shibani Malhotra wrote in a research
note last week that the treatment could have sales of $150
million in 2017 and add 24 cents per share to earnings that
An FDA approval could underpin Allergan's efforts to resist
the takeover, Malhotra wrote. If the company received a
so-called complete response letter from the agency instead, the
letter "may have the opposite effect," the analyst wrote.
The new treatment will be administered by inhaler rather
than the currently available nasal sprays and injectables. The
items in the letter have to do with "content uniformity on the
improved canister filling process and on standards for device
actuation" for the migraine treatment, Allergan said.
(Reporting by Caroline Humer; Editing by Lisa Von Ahn)