New Oral Rosacea Drug Gains Tentative FDA Approval

FDA grants Fast Track status to oliceridine
FDA grants Fast Track status to oliceridine

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. 

RELATED: Rosacea Linked to Increased Risk of Glioma

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. 

For more information visit DrReddys.com or PromiusPharma.com.

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