Dr. Reddy's and its Subsidiary Promius Pharma File Three NDAs

Dr. Reddy's Laboratories and its subsidiary, Promius Pharma, LLC filed three 505(b)(2) New Drug Applications (NDAs) with the 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. 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. 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.

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.