Sun Pharma's Generic Loteprednol Etabonate Receives Approval in the U.S.
Enforcement Report - Week of July 26, 2023
Alcon has expanded its portfolio of eye disease products by paying $60 million upfront for the rights to two commercial products based on mucus-penetrating particle drug delivery technology. The sale of the assets extends Kala Pharmaceuticals’ cash runway past phase 2/3 data on another drug candidate.
GENEVA--(BUSINESS WIRE)-- Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced it has signed an agreement to acquire EYSUVIS® (loteprednol etabonate suspension) 0.25% pharmaceutical eye drops from Kala Pharmaceuticals, Inc.
Akorn Inc`s Generic Loteprednol Etabonate Receives Approval In US
Akorn Inc`s Generic Loteprednol Etabonate Receives Approval In US
LAKE FOREST, Ill., Feb. 11, 2021 /PRNewswire/ -- Akorn Operating Company LLC (Akorn), a leading specialty pharmaceutical company, announced that it received approval of its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Loteprednol Etabonate Ophthalmic Gel, 0.5%.
WATERTOWN, Mass.--(BUSINESS WIRE)--Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) resubmission for EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, its product candidate for the short-term treatment of the signs and symptoms of dry eye disease. The FDA stated that the NDA resubmission is a complete, Class 2 response to the Complete Response Letter (CRL) issued in August 2019, and the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2020 for the completion of its review of the NDA.