08.04.2015 05:22:49

Dr. Reddy's Labs Announce Filing Of Three NDAs With U.S FDA - Quick Facts

(RTTNews) - Dr. Reddy's Laboratories (RDY) and its subsidiary, Promius Pharma, LLC announced the filing of three 505(b)(2) New Drug Applications or NDAs with the U.S. Food and Drug Administration.

The three NDAs - DFD-01, DFD-09, and DFN-11, are in support of Dr. Reddy's Proprietary Products group, focused on developing and commercializing therapies in dermatology and neurology.

DFD-01 is a corticosteroid delivered in a novel non-irritating spray platform, intended for the treatment of patients suffering from psoriasis. DFD-09 is a modified release oral tetracycline intended for the treatment of rosacea.

DFN-11 is a drug-device combination product intended to treat acute migraine episodes in certain patient populations who are inadequately managed with existing treatment regimens.

Upon approval, the products will be commercialized by Promius Pharma.

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