COPENHAGEN |
Wed Dec 12, 2012 2:44pm EST
COPENHAGEN (Reuters) – Danish curative organisation H Lundbeck A/S pronounced on Wednesday a U.S. Food and Drug Administration (FDA) has supposed a acquiescence of a new drug focus for an antidepressant.
Lundbeck and a Japanese partner Takeda Pharmaceutical Co Ltd submitted a new antidepressant, vortioxetine, for regulatory capitulation in a United States in October.
Upon a acceptance of a filing by a FDA, Lundbeck would accept a miracle remuneration of $50 million from Takeda, a association pronounced in a statement.
Lundbeck hopes a new calmative will yield a new source of income as a pivotal anti-depressant, Cipralex, sole as Lexapro in a United States and Japan, comes off obvious protection.
The association has already warned that gain will case until 2015 due to inexpensive general competition, definition new products will be critical for destiny earnings.
According to a timelines determined by a Prescription Drug User Fee Act, a examination of drug focus is targeted for execution by Oct 2 subsequent year.
(Reporting by Mette Fraende; Editing by Gerald E. McCormick)
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