COPENHAGEN Dec 12 Danish pharmaceutical group H
Lundbeck A/S said on Wednesday the U.S. Food and Drug
Administration (FDA) has accepted the submission of a new drug
application for an antidepressant.
Lundbeck and its Japanese partner Takeda Pharmaceutical Co
Ltd submitted the new antidepressant, vortioxetine, for
regulatory approval in the United States in October.
Upon the acceptance of the filing by the FDA, Lundbeck would
receive a milestone payment of $50 million from Takeda, the
company said in the statement.
Lundbeck hopes the new antidepressant will provide a new
source of revenue as its key anti-depressant, Cipralex, sold as
Lexapro in the United States and Japan, comes off patent
The company has already warned that earnings will stall
until 2015 due to cheap generic competition, meaning new
products will be vital for future earnings.
According to the timelines established by the Prescription
Drug User Fee Act, the review of drug application is targeted
for completion by Oct. 2 next year.