Aerie Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
FDA review period for RoclatanTM NDA is only ten months instead of twelve months because Aerie’s submission is filed under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, since RoclatanTM is a fixed dose combination of two previously approved drugs in the United States.
“The RoclatanTM NDA filing represents another significant achievement for Aerie this year, on top of our recent commercial launch of Rhopressa® in
the United States. Since RoclatanTM is being filed through the 505(b)(2) regulatory pathway, in which both active ingredients, netarsudil and latanoprost, are already approved in the United States, we expect a ten-month FDA review. We believe, if approved, RoclatanTM has the potential to be the most efficacious therapy in the market for the reduction of IOP, which makes this submission all the more exciting for our valued employees, eye care professionals, and most importantly, patients who suffer from glaucoma or ocular hypertension,” said Vicente Anido, Jr., Ph.D., Chief Executive Officer and Chairman at Aerie.