 "Dr Reddy's files 3 new drug applications with US regulator")
Dr Reddy's Laboratories and its subsidiary, Promius Pharma LLC, have filed three new drug applications (NDAs) in support of the company's proprietary products group 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," the company said in a statement.
According to Dr Reddy's, DFD-01 and DFD-09 are the first dermatology applications submitted to the NDA that have been fully developed leveraging in-house capabilities. The first one is a corticosteroid delivered in a non-irrigating spray platform, intended for the treatment of patients suffering from psoriasis. The second one 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, the company said. It is a drug-device combination product intended to treat acute migraine episodes in certain patients, who are inadequately managed with existing treatment regimes.
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 commercialised by Promius Pharma, the company said.