On Air Now

Upcoming Shows

Program Schedule »

Tune in to Listen

Listen Live Now » 1440 AM Green Bay, WI

Weather

Current Conditions(Green Bay,WI 54303)

More Weather »
55° Feels Like: 55°
Wind: NNW 10 mph Past 24 hrs - Precip: 0.25”
Current Radar for Zip

Today

AM Showers 59°

Tonight

Clear 39°

Tomorrow

Mostly Sunny 68°

Alerts

  • 0 Severe Weather Alerts
  • 0 Cancellations

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)

Comments