- 6E10 combined with local prophylaxis selected for Phase 3 pivotal trials, with a favorable safety profile and potential best-in-class product profile at 26 weeks - Efficacy: 76% of 6E10...
Epic Pharma`s Generic Difluprednate Receives Approval in the U.S
HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Dr. Reddy’s Difluprednate Ophthalmic Emulsion 0.05%, a therapeutic generic equivalent to Durezol® (Difluprednate Ophthalmic Emulsion 0.05%) in the U.S. market, following the approval by the U.S. Food and Drug Administration (USFDA).
Dr. Reddy's Generic Difluprednate Receives Approval in the U.S.
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BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for difluprednate ophthalmic emulsion 0.05%, which is the generic version of Durezol® and is used in the treatment of inflammation and pain associated with ocular surgery.
Amneal Pharma's Generic Difluprednate Receives Approval in the US
The purpose of this study is to investigate the process of drug distribution and mechanism of drug release of ophthalmic emulsions in the context of factors associated with the drug release. Cyclosporine and difluprednate emulsions were chosen as model systems.