 "Dr Reddy's gets tentative USFDA nod for anti-inflammatory drug")
Dr Reddy's Laboratories Limited has received a tentative approval from the US Food and Drug Administration (USFDA) for Zenavod (doxycycline) capsules. Zenavod is a tetracycline-class drug indicated for the treatment of only inflammatory lesions of rosacea in adult patients.
Promius Pharma, the US subsidiary of Dr Reddy's Laboratories will be responsible for commercialising Zenavod in the US market, according to a press release issued today.
"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 of 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 ".
The approval of the new drug application (ANDA) is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy for approval, but it is subject to an automatic stay of final approval for up to 30 months pending a patent infringement process under an American law, according to the company.
