Dr. Reddy's Lab (DRL) has received tentative approval from the US health regulator for anti-biotic Zenavod indicated for the treatment of a type of chronic skin disease in adult patients.
The approval by the US Food and Drug Administration (USFDA) for doxycycline capsules (Zenavod) is of strength 40 mg.
The approval of the new drug application is tentative because the FDA 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 of up to 30 months pending a patent infringement process under the Drug Price competition and Patent Term Restoration Act, it added.
