Dr Reddy's Laboratories today said it has received first cycle new drug application (NDA) approval from the US health regulator for its psoriasis treatment Impoyz cream.
The company through its wholly-owned subsidiary Promius Pharma, LLC, has received its fifth consecutive, first-cycle NDA approval from the US Food and Drug Administration (USFDA) for the Proprietary Products Group, Dr Reddy's Laboratories said in a statement.
"We are looking forward to working with our partner, Encore Dermatology, to bring this novel treatment to providers and their patients," Promius Pharma President and Senior Vice President, Proprietary Products Anil Namboodiripad said.
Impoyz, formerly referred to as DFD-06, had been recently licensed to Encore Dermatology Inc for the commercialisation of the product in the US. Impoyz (clobetasol propionate) Cream is a high potency topical steroid approved for the treatment of moderate to severe plaque psoriasis in patients 18 years of age or older, it added.
Psoriasis affects around 7.5 million people in the US. Dr Reddy's shares were trading 2.22 per cent down at Rs 2,235.60 apiece on BSE today.
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