Tuesday, 24 April 2018

Dr. Reddy’s achievement: Got first-cycle NDA approval of Impoyz cream

01 December 2017 | News

Impoyz (clobetasol propionate) Cream, 0.025% is a high power topical steroid approved for the treatment of moderate to severe plaque psoriasis in adults.

Dr. Reddy’s Laboratories Ltd., through its wholly owned subsidiary Promius Pharma, LLC, today announced its fifth consecutive, first-cycle NDA approval for the Proprietary Products Group, a substantial milestone within the pharmaceutical industry. 

Impoyz (clobetasol propionate) Cream, 0.025% is a high potency topical steroid approved for the treatment of moderate to severe plaque psoriasis in patients 18 years of age or older.

The most common side effect of IMPOYZ Cream includes discoloration of the treated site. Psoriasis is a serious medical condition affecting approximately 7.5 million people in the United States.

Impoyz, formerly referred to as DFD-06, had been recently licensed to Encore Dermatology Inc. for the commercialization of the product in the United States.

This approval is another example of the deep and broad capabilities within the Proprietary Products business unit at Dr. Reddy’s.

The organization has achieved several milestones within drug, device, and formulation research and development for novel therapies.

 “The fifth consecutive first cycle NDA approval represents Dr. Reddy’s long-term commitment to building an organization that delivers innovative medical solutions,” said Anil Namboodiripad, Senior Vice President, Proprietary Products and President, Promius Pharma. “We are looking forward to working with our partner, Encore Dermatology, to bring this novel treatment to providers and their patients.”

“Encore is excited about adding another great product to our portfolio and looking forward to the opportunity to commercialize a new product for the treatment of mild to moderate psoriasis as well as broadening our portfolio outside of atopic dermatitis and acne,” said Robert Moccia, CEO, Encore Dermatology, Inc.

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