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Dr Reddy’s gets USFDA nod to market Sernivo spray
Drug major Dr Reddy\'s Laboratories Ltd on Tuesday said its US subsidiary Promius Pharma has received USFDA approval to market Sernivo spray, used in treatment of skin disorder. The company plans to launch the product in the coming quarter, it said in a release.
Hyderabad: Drug major Dr Reddy's Laboratories Ltd on Tuesday said its US subsidiary Promius Pharma has received USFDA approval to market Sernivo spray, used in treatment of skin disorder. The company plans to launch the product in the coming quarter, it said in a release.
The product is a prescription topical steroid and is being used in the treatment of mild to moderate plaque psoriasis in the patients of 18 years or older, it added.
Responding in a statement, the company Co-Chairman and CEO GV Prasad stated: "The FDA approval of Sernivo Spray is a significant milestone for Promius as it validates our committed efforts and resources to developing differentiated dermatology products from concept to commercial launch. We look to expand our portfolio of medical dermatology products available in the US market."
Promius has conducted two successful multi-center, randomized, double-blind, vehicle-controlled clinical trials in subjects aged 18 years and older and in both trials, randomized subjects applied Sernivo Spray or vehicle spray to the affected areas twice daily for 28 days, the release added.
Its executive vice-President, Raghav Chari said, "As an emerging leader in the dermatology space, we are committed to developing innovative treatment options and support services for clinicians and patients."