German drug firm
said Wednesday that the U.S. launch of its highly anticipated impotence drug Vardenafil will be delayed until next year.
The Food and Drug Administration issued an approvable letter for Vardenafil, also known by its brand name, Nuviva, but the agency asked for additional studies to be performed before granting final approval.
Bayer was hoping to launch Vardenafil in the fourth quarter of this year, but that's now delayed until 2003, the company said. The drug is expected to compete against Viagra, marketed by Pfizer.
The FDA action is doubly frustrating for Bayer because Vardenafil had a chance to get to market before another new impotence drug, Cialis, which is being developed by
Cialis has also been delayed by FDA requests for more clinical information, pushing back an expected launch from the second half of this year to next year.
Bayer is codeveloping Vardenafil with