Dr. Reddy’s Laboratories’ U.S. subsidiary Promius Pharma LLC has received U.S. Food and Drug Administration approval for Sernivo (betamethasone dipropionate) spray (0.05%), a product used in the treatment of psoriasis.
The commercial launch of the product is planned for the coming quarter, said a Dr.Reddy’s release on Monday about receipt of the USFDA nod.
“We are delighted to receive a first round FDA approval of Sernivo Spray as we look to expand our portfolio of medical dermatology products available in the US market,” said Dr. Reddy’s co-chairman and CEO G.V. Prasad.
Sernivo spray is a prescription topical steroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.
Promius, the release said, conducted “two successful multi-centre, randomized, 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.”
