Dr. Reddy’s Laboratories announced today the U.S. Food and Drug Administration (US FDA) tentative approval for Zenavod (doxycycline) Capsules, 40 mg.  Zenavod is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. Promius Pharma, LLC, the U.S. subsidiary of India’s Dr. Reddy’s Laboratories will be responsible for commercializing Zenavod in the U.S. market.

“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,” stated G V Prasad, CEO and Co-Chairman, Dr. Reddy’s Laboratories.  He continued, “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 (NDA) 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 for up to 30 months pending a patent infringement process under the Drug Price Competition and Patent Term Restoration Act (“Hatch Waxman”).

“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.”

INDICATION:

ZENAVOD is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.

Important safety information

ZENAVOD Capsules do not lessen the facial redness caused by rosacea.  Some of the most common adverse reactions of doxycycline (incidence >2% and more common than with placebo) are nasopharyngitis, sinusitis, fungal infection, influenza, diarrhea, upper abdominal pain, hypertension, lactate dehydrogenase increase, anxiety and pain.  Pseudomembranous colitis can occur with doxycycline therapy as can intracranial hypertension, and autoimmune syndromes. ZENAVOD Capsules should not be used to treat or prevent infections. ZENAVOD Capsules should not be taken by patients who have a known hypersensitivity to doxycycline or other tetracyclines. ZENAVOD Capsules should not be taken during pregnancy, by nursing mothers, or during tooth development (up to the age of 8 years).  Photosensitivity can occur with doxycycline; patients should minimize or avoid exposure to natural or artificial sunlight. The efficacy of ZENAVOD Capsules treatment beyond 16 weeks and safety beyond 9 months have not been established.