Dr. Reddy's Receives FDA Tentative Approval For Zenavod Capsules

Dr. Reddy's Laboratories Ltd (ADR) (NYSE: RDY), a global pharmaceutical company that is engaged in providing medicines, announced on Monday that the U.S. Food and Drug Administration offered a tentative approval for the company's Zenavod 40 mg capsules.

Zenavod is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

Shares of Dr. Reddy's Laboratories were trading higher by just 0.47 percent at $45.14 1 hour after Monday's opening bell.

Dr. Reddy's noted the approval is tentative because the FDA has determined that the drug meets all of the pre-conditions including quality, safety and efficacy standards. However, the drug is subject to an automatic stay of final approval for up to 30 months pending a patent infringement process.

"The tentative approval for Zenavod is another step toward providing an additional option for people with rosacea in the U.S., who need oral treatment," said Dr. Raghav Chari, Executive Vice President of Proprietary Products at Dr. Reddy's and President of Promius Pharma, "We are looking forward to the commercial launch and continuing to enhance our support of medical dermatologists and their patients."

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