Dr Reddy's gets tentative approval from USFDA for Zenavod
New Delhi: Dr Reddy's Laboratories (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. Zenavod is a tetracycline-class drug indicated for treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients, the firm said in BSE filing.
Promius Pharma LLC, the company's US arm will be responsible for commercialising Zenavod in the US market, it added.
Dr Reddy's CEO and Co-Chairman G V Prasad said: "The development confirms our ability and commitment to develop differentiated dermatology products leveraging the in-house capabilities of Promius Pharma LLC and Dr Reddy's."
DRL will be working with external parties and the USFDA to gain a full approval, he added.
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.
"The tentative approval of Zenavod is another step toward providing an additional option for people with rosacea in the US who need oral treatment," DRL Executive Vice-President (Proprietary Products) and Promius Pharma President Raghav Chari said.
Shares of DRL were trading at Rs 3,093.95 in the afternoon trade, down 0.31 per cent on BSE.
The approval by the US Food and Drug Administration (USFDA) for doxycycline capsules (Zenavod) is of strength 40 mg. Zenavod is a tetracycline-class drug indicated for treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients, the firm said in BSE filing.
Promius Pharma LLC, the company's US arm will be responsible for commercialising Zenavod in the US market, it added.
Dr Reddy's CEO and Co-Chairman G V Prasad said: "The development confirms our ability and commitment to develop differentiated dermatology products leveraging the in-house capabilities of Promius Pharma LLC and Dr Reddy's."
DRL will be working with external parties and the USFDA to gain a full approval, he added.
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.
"The tentative approval of Zenavod is another step toward providing an additional option for people with rosacea in the US who need oral treatment," DRL Executive Vice-President (Proprietary Products) and Promius Pharma President Raghav Chari said.
Shares of DRL were trading at Rs 3,093.95 in the afternoon trade, down 0.31 per cent on BSE.
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