Dr Reddyâs US subsidiary, Promius Pharma has received theÂ approval for Sernivo (betamethasone dipropionate) Spray,Â 0.05 per cent from the US Food and Drug AdministrationÂ (FDA). Sernivo Spray, a prescription topical steroid, is indicatedÂ for the treatment of mild to moderate plaque psoriasis in patientsÂ 18 years of age or older. The commercial launch of theÂ product is planned for the coming quarter.
G V Prasad, Co-Chairman and CEO, Dr Reddyâs Laboratories said, âThe FDA approval of Sernivo Spray is significant milestone for Promius, asÂ it validates our committed efforts and resources to developing differentiated dermatology products from concept to commercial launch. We are delighted to receive a first round FDA approval for theÂ spray. We look to expand our portfolio of medical dermatologyÂ products available in the US market.â
Promius has conducted two successful multi-center, randomised, double-blind, vehicle-controlled clinical trials in subjects aged 18 years and older with moderate plaque psoriasis to evaluate the safety and efficacy of Sernivo Spray. In both trials, randomised subjects applied Sernivo Spray or vehicle spray to the affected areas twice daily for 28 days.