Article
Allergan receives approvable letter for glaucoma drug
The FDA issued an approvable letter to Allergan Inc. that will allow additional clinical investigation of the company's timolol combination product, bimatoprost 0.03%/timolol 0.05% ophthalmic solution (Lumigan), for glaucoma.
The FDA issued an approvable letter to Allergan Inc. that will allow additional clinical investigation of the company's timolol combination product, bimatoprost 0.03%/timolol 0.05% ophthalmic solution (Lumigan), for glaucoma.
An approvable letter sets out the conditions that a company must meet in order to obtain FDA final marketing approval.
"The FDA's response necessitates additional clinical investigation," said Scott Whitcup, MD, executive vice president, research and development, Allergan, in a company statement. "Allergan has already initiated an additional clinical study that we currently anticipate will be completed by the end of 2004."
