DRL, Promius Pharma files NDAs with US FDA

Dr Reddy’s Laboratories and its subsidiary, Promius Pharma announced the filing of three 505(b)(2) New Drug Applications (NDAs) with the US 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 commercialising 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 programme 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.

Raghav Chari, Executive Vice President of Proprietary Products, Dr Reddy’s and President, 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 commercialised by Promius Pharma.

EP News BureauMumbai