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Dr Reddy’s gets tentative USFDA nod for Zenavod
City-based Dr Reddy\'s Laboratories on Monday said it secured tentative approval from the US health regulator, USFDA, for for Zenavod (doxycycline) capsules, 40 mg. Zenavod is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
Hyderabad: City-based Dr Reddy's Laboratories on Monday said it secured tentative approval from the US health regulator, USFDA, for for Zenavod (doxycycline) capsules, 40 mg. Zenavod is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
Promius Pharma, LLC, the US subsidiary of Dr. Reddy's Laboratories, will commercialise the capsules in the American market, the pharma major said without indicating timeline for the launch. “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,” said G V Prasad, CEO and co-Chairman, Dr. Reddy’s.
We are pleased to receive a tentative FDA approval of Zenavod and will be working with external parties and the FDA to gain a full approval, he added. The approval of the New Drug Application (NDA) is tentative because the USFDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but it is subject 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.
“The tentative approval for Zenavod is another step toward providing an additional option for people with rosacea in the US, who need oral treatment,” said Dr Raghav Chari, President, Promius Pharma. We are looking forward to the commercial launch and continuing to enhance our support of medical dermatologists and their patients, he added.