Dr. Reddy’s Lab, Promius Pharma announces filing of three NDAs with USFDA

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. 

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.

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