Aerie withdraws Rhopressa NDA on manufacturing delay

Aerie Pharmaceuticals Inc. (NASDAQ:AERI) said it withdrew its NDA for Rhopressa netarsudil ophthalmic solution 0.02% to treat intraocular pressure in glaucoma and ocular hypertension patients. It had submitted the application to FDA last month.

Aerie said a third-party manufacturing facility was not prepared for pre-approval inspection. The company expects the issue to be resolved in January 2017, when it plans to re-submit the NDA. ...