The debt-ridden company is counting on the drug - fremanezumab -
along with Huntington's treatment Austedo, to help it return to
growth.
Teva and Eli Lilly are in a race to put a second migraine drug on
the market, after rival Amgen won FDA approval last week for Aimovig
to prevent migraine headaches in adults.
Lilly has said it expects an FDA decision on its galcanezumab drug
by the third quarter.
"We are preparing to launch the product immediately when approved,"
said Brendan O'Grady, head of Teva's North America Commercial
division in a statement. "Migraine patients have waited years for
new preventive treatments to enter the market."
Israel-based Teva had initially hoped to receive approval for
fremanezumab by June but concerns raised by the U.S. Food and Drug
Administration in February over the manufacturing facility at Teva's
partner Celltrion <068270.KS> in South Korea delayed approval.
Last month Teva, the world's largest generic drugmaker, said it
would be delayed until no later than the end of 2018.
Teva said on Wednesday that the FDA's prescription drug user fee act
(PDUFA) action date was set for Sept. 16, when the FDA will likely
make its decision on fremanezumab, which comes in monthly and
quarterly doses.

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It noted that there had been no additional data requests from the
FDA.
"Our primary goal is to bring preventive treatment options to
migraine patients as quickly as possible," said Hafrun
Fridriksdottir, executive vice president of Teva's global R&D. "We
are encouraged by the ongoing communications with the FDA as we work
to bring this important therapy to patients."
Teva's share price has fallen 30 percent since last August due to a
decline in U.S. generic drug prices and copycat competition for its
blockbuster multiple sclerosis drug Copaxone.

Its shares were up 0.1 percent at $21.03 in early Nasdaq trading.
Teva also was saddled with $35 billion in debt from its $40.5
billion purchase in 2016 of Allergan's generic drug business Actavis,
forcing it to sell assets. Its gross debt stood at $30.8 billion as
of March 31.
(Reporting by Steven Scheer; Editing by Ari Rabinovitch and Susan
Fenton)
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