Drug major Dr Reddy's Laboratories Ltd announced on Monday its US subsidiary Promius Pharma Llc has received approval for the anti-psoriasis spray Sernivo from the US Food and Drug Administration (FDA). Sernivo (betamethasone dipropionate) is used to treat mild-to-moderate plaque psoriasis in patients who are 18 years or older.
Sernivo's commercial launch is planned for the coming quarter, as per a statement issued by the company. G V Prasad, Co-Chairman and CEO of Dr Reddy's Laboratories, said in a statement: "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 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."
The company added that Promius has conducted two multi-centre 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 the Sernivo spray.
Raghav Chari, Executive Vice-President of Proprietary Products , Dr Reddys and President, Promius Pharma, said in a statement: "The approval of Sernivo emphasises our ongoing efforts and we look forward to a successful launch of Sernivo Spray in the coming quarter."
This is the second FDA approval for Dr Reddy's this month. On February 1, the company announced the tentative approval for Zenavod (doxycycline) capsules, 40 mg, for treatment of inflammatory lesions of rosacea in adult patients.
On February 8, Dr Reddys Laboratories closed at the BSE at Rs 3,070.65, down Rs 38.4, or 1.24 percent. The 52-week high of the share was Rs 4,382.95 and the 52-week low was Rs 2,750.00 on the index.