Extravan gets ‘approvable’ letter from FDA
FORT WORTH, Texas A fixed combination glaucoma drug is one step closer to receiving U.S. regulatory approval, according to Alcon, the products manufacturer.
Alcon announced that the Food and Drug Administration has issued an approvable letter for Extravan ophthalmic solution for the treatment of glaucoma. Extravan solution is a fixed combination of travoprost 0.004% and timolol 0.5%.
We will be meeting with the FDA as soon as possible to clarify what additional steps may be required to gain final approval to market Extravan, Scott Krueger, MD, Alcon's vice president of regulatory affairs, said in a press release.