Lundbeck gets U.S. nod for antidepressant submission
COPENHAGEN (Reuters) - 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 protection.
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 October 2 next year.
(Reporting by Mette Fraende; Editing by Gerald E. McCormick)