Dr.Reddy’s Sernivo spray gets USFDA nod

Chennai, Feb 8 (IANS) 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.

Leave a Reply

Please enter your comment!

The opinions, views, and thoughts expressed by the readers and those providing comments are theirs alone and do not reflect the opinions of www.mangalorean.com or any employee thereof. www.mangalorean.com is not responsible for the accuracy of any of the information supplied by the readers. Responsibility for the content of comments belongs to the commenter alone.  

We request the readers to refrain from posting defamatory, inflammatory comments and not indulge in personal attacks. However, it is obligatory on the part of www.mangalorean.com to provide the IP address and other details of senders of such comments to the concerned authorities upon their request.

Hence we request all our readers to help us to delete comments that do not follow these guidelines by informing us at  info@mangalorean.com. Lets work together to keep the comments clean and worthful, thereby make a difference in the community.

Please enter your name here