Biofrontera: FDA Approves SNDA To Increase Maximally Approved Dosage Of Ameluz - Quick Facts

(RTTNews) - Biofrontera (BFRI) announced the FDA has approved the company's sNDA to increase the maximally approved dosage from one to three tubes of Ameluz per treatment. The sNDA was supported by two clinical Phase I safety studies in which three tubes of Ameluz were applied to 116 patients. The company noted that the approval allows for larger field treatment of actinic keratosis on face and scalp with Ameluz-PDT using the BF-RhodoLED or the RhodoLED XL lamp.

Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, said: "We are now working with Medicare and commercial payers to obtain reimbursement for this label update and will notify our customers accordingly."

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