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Dr.Reddy's Sernivo spray gets USFDA nod
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SME Times News Bureau | 08 Feb, 2016
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.
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.
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