Dr. Reddy’s Laboratories and its subsidiary filed three NDAs for psoriasis, rosacea and migraine

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

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 and DFD-09 are the first dermatology applications submitted to the NDA that have been fully developed leveraging in-house capabilities. 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 the first development program filed in support of a newly created vertical, focused on the US neurology market. 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.

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Commenting on the filings, Raghav Chari, Executive Vice President of Proprietary Products at Dr. Reddy’s and President of Promius Pharma™ said: “These products potentially represent new, compelling options for specific segments of patients suffering from Psoriasis, Rosacea and Migraine. They are also the first of a large basket of products targeting conditions predominantly treated by the medical dermatologist and neurologist. By focusing exclusively on these two specialty therapeutic areas, we intend to build a leading presence in them over time.”

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

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