FDA completes Biofrontera’s Ameluz® NDA mid-cycle review
Biofrontera , the biopharmaceutical company focusing on sun-induced skin cancer, announced recent progress on the ongoing approval process for Ameluz® and BF-RhodoLED® in the USA. FDA has now completed its mid-cycle review of the Ameluz® NDA (new drug application). The review resulted in no additional requests for material nor were any additional review issues highlighted.
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Ameluz® is a prescription drug used in combination with Biofrontera’s proprietary lamp, BF-RhodoLED®, as a photodynamic therapy (PDT) to treat actinic keratosis.
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Ameluz® is currently approved in the EU and Switzerland. With European sales continuously growing, an approval in the USA would create a significantly larger market opportunity for Biofrontera. The US market opportunity for Ameluz® and BF-RhodoLED® is particularly promising since PDT for actinic keratosis is a fully reimbursed Medicare procedure, which is not generally the case in Europe.