Dr Reddy's Laboratories (DRL) has received tentative approval from the US Food and Drug Administration for antibiotic drug, doxycycline capsules (Zenavod), a tetracycline-class drug indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients.
Promius Pharma, the company's US arm, will be responsible for commercialising Zenavod in the US market.
"The development confirms our ability and commitment to develop differentiated dermatology products leveraging the in-house capabilities of Promius Pharma and Dr Reddy’s,’’ G V Prasad, CEO and Co-chairman, Dr Reddy’s, said in a release issued here on Monday.
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.
The approval of Zenavod was another step towards providing an additional option for people with rosacea in the US who needed oral treatment, Raghav Chari, Executive Vice-President (Proprietary Products), Dr Reddy’s, and President of Promius Pharma, said.
Dr Reddy’s scrip remains almost steady on the Bombay Stock Exchange on Monday and was trading at Rs 3,093.20.