Posted by Michael Wonder on 26 May 2020
Kala Pharmaceuticals announces FDA acceptance of new drug application for Eysuvis for dry eye disease
26 May 2020 - FDA sets PDUFA goal date of 30 October 2020.
Kala Pharmaceuticals today announced that the U.S. FDA has accepted for review the company’s new drug application resubmission for Eysuvis (loteprednol etabonate 0.25% ophthalmic suspension) its product candidate for the short-term treatment of the signs and symptoms of dry eye disease.
The FDA stated that the resubmission is a complete, Class 2 response to the complete response letter issued in August 2019, and the FDA set a Prescription Drug User Fee Act goal date of 30 October 2020 for the completion of its review of the application.
