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26 April, 2024 10:46 IST
Dr Reddy's US arm receives USFDA approval for Sernivo spray
Source: IRIS | 08 Feb, 2016, 09.16AM
Rating: NAN / 5 stars.
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Dr Reddys Laboratories, an integrated global pharmaceutical company, announced today that its US subsidiary, Promius Pharma has received approval from the U.S. Food and Drug Administration (USFDA) for Sernivo (betamethasone dipropionate) spray, 0.05%.

Sernivo spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. The commercial launch of the product is planned for the coming quarter.

G V Prasad, co-chairman and CEO, Dr. Reddy's Laboratories said, ''The USFDA 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 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.''

Raghav Chan, executive vice president of proprietary products at Dr. Reddy's and president of Promius Pharma said, ''As an emerging leader in the dermatology space, we are committed to developing innovative treatment options and support services for clinicians and patients. The approval of Semivo emphasizes our ongoing efforts and we look forward to a successful launch of Sernivo spray in the coming quarter.''

Promius has conducted two successful multi-center, 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.

Shares of the company declined Rs 9.5, or 0.31%, to trade at Rs 3,099.55. The total volume of shares traded was 9,301 at the BSE (10.46 a.m., Monday).

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