FDA to Review Biofrontera’s sNDA for Ameluz Dosage Increase
The U.S. Food and Drug Administration (FDA) has issued a “no filing review issues identified” letter regarding Biofrontera’s sNDA (supplementary New Drug Application) which aims to increase the maximally approved dosage from one to three tubes of Ameluz per treatment. The FDA has completed its filing review and will begin its substantive review of Biofrontera’s communication with […]