Dr. Reddy’s Laboratories has received US Food and Drug Administration (USFDA) tentative approval 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 India’s Dr. Reddy’s Laboratories will be responsible for commercializing Zenavod in the US market.
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 (Hatch Waxman).
Dr. Reddy's Laboratories, is a multinational pharmaceutical company based in Hyderabad, Telangana in India. Dr. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas.
