New Oral Rosacea Drug Gains Tentative FDA Approval
Dr. Reddy's Laboratories announced that the Food and Drug Administration (FDA) has granted tentative approval for Zenavod (doxycycline) capsules for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults.
Zenavod is a tetracycline-class antibiotic indicated for various bacterial infections, acne, malaria, and periodontal disease. Its exact mechanism of action in the treatment of rosacea is unknown.
The tentative approval of the New Drug Application (NDA) is subject to an automatic stay of final approval for up to 30 months pending a patent infringement process.
Zenavod will be available as 40mg strength capsules. It will be commercialized by Promius Pharma, a subsidiary of Dr. Reddy's Laboratories.