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Monday, February 01, 2016

Dr Reddy's gets tentative USFDA nod for Zenavod Capsules

Pharma giant, Dr Reddys Laboratories Ltd said that it has received tentative approval from US Food and Drug Administration (US FDA) for Zenavod Capsules for the treatment of Rosacea in adults. “Zenavod is a tetracycline-class drug indicated for the treatment of only inflammatory lesions of rosacea in adult patients,” the company said in a filing to the Bombay Stock Exchange. Promius Pharma LLC. the U.S. subsidiary of India’s Dr Reddys Laboratories will be responsible for commercializing Zenavod in U.S. market, added the filing. Commenting on the development, Dr Reddys Laboratories, CEO and Co-Chairman, G V Prasad said, “This development confirms our ability and commitment to develop differentiated dermatology products leveraging the in-house capabilities of Promius Pharma, LLC and Dr. Reddy’s.” The approval of the new drug application is tentative because the FDA has determined that the drug meets all of the requires quality, safety and efficacy standards for approval, but it is subject to an automatic stay of final approval for upto 30 months pending a patent infringement process under the Drug Price Competition and Patent Term Restoration Act. Meanwhile, shares of the company were trading at Rs 3094.90 apiece, down 0.28 per cent from the previous close at 12:44 hours on BSE.