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."