Wednesday, March 1, 2017

Aerie Pharmaceuticals Resubmits NDA

Irvine-based pharmaceuticals developer Aerie Pharmaceuticals said today that it has resubmitted an NDA (New Drug Application) for its Rhopressa (netarsudil ophthalmic solution) for treating glaucoma, to the FDA. The company said its earlier submission had been withdrawn in October of 2016, due to issues with its contract drug product manufacturer. Aerie said that its vendor's Tampa, Florida facility is now ready for pre-approval inspection by the FDA, the issue which had caused it to withdraw its application earlier for approval and review. The company is now targeting the second quarter of 2018 to launch its product.