Hyderabad: Dr. Reddy’s Laboratories Ltd (DRL) said its US subsidiary Promius Pharma, LLC, received fifth consecutive and final approval for its specialty drug Impoyz (clobetasol propionate) cream, 0.025 percent, from the US Food and Drug Administration.
A statement from the drug maker said it is a first-cycle NDA (new drug application) approval for the Proprietary Products Group, a substantial milestone in the pharmaceutical industry.
Impoyz (clobetasol propionate) cream, 0.025 percent, is a high-potency topical steroid approved for the treatment of moderate to severe plaque psoriasis in patients 18 years of age or older.
This approval is another example of the deep and broad capabilities of 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, it said.
Anil Namboodiripad, Senior Vice President, Proprietary Products and President Promius Pharma, said they are looking forward to working with their partner, Encore Dermatology, to commercialize.
“The fifth consecutive first cycle NDA approval represents Dr. Reddy’s long-term commitment to building an organization that delivers innovative medical solutions. We are looking forward to working with our partner, Encore Dermatology, to bring this novel treatment to providers and their patients,” Namboodiripad said.
“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 of Encore Dermatology Inc, said.
The most common side effect of Impoyz cream includes discoloration of the treated site, the release said.
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, it added.