Dr.Reddy's Sernivo spray gets USFDA approval
| Monday, February 8, 2016 - 16:57
Chennai: Indian drug major Dr.Reddy's Laboratories Ltd on Monday said its wholly owned US subsidiary Promius Pharma has got the USFDA for a spray to treat plaque psoriasis.
In a regulatory filing in the BSE, Dr.Reddy's said its American subsidiary Promius Pharma has got the US Food and Drug Administration's (USFDA) nod for Sernivo Spray, a prescription topical steroid for treatment of mild to moderate plaque psoriasis for patients 18 years and above.
"The commercial launch of the product is planned for the coming quarter," the company said.
Commenting on the approval, G V Prasad, co-chairman and CEO, Dr. Reddy's Laboratories said: "The FDA approval of Sernivo Spray is a significant mile stone for Promius, as it validates our committed efforts and resources to developing differentiated dermatology products from concept to commercial launch."
He said the company will look to expand its portfolio of medical dermatology products available in the US market.
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This is the second USFDA approval for Dr.Reddy's this month. On February 1, the Indian company said it got the tentative approval for Zenavod (doxycycline) capsules, 40 mg for treatment of inflammatory lesions of rosaea in adult patients.
According to Dr.Reddy's he approval of the New Drug Application (NDA) is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but it is subjected to an automatic stay of final approval for up to 30 months pending a patent infringement process under the Drug Price Competition and Patent Term Restoration Act.