The pre-NDA (new drug application) meeting, set for 8 October, represents the last opportunity to obtain direct feedback from the US regulator prior to the application.
Ameluz is a prescription drug approved in Europe for the treatment of mild to moderate actinic keratosis. BF-RhodoLED is a CE-marked red light LED lamp used in combination with Ameluz in photodynamic therapy (PDT). Both products are already sold in most major European markets.
After the FDA requested additional studies in 2012, Biofrontera has performed two phase I trials and one phase III study, results of which are due at the end of September or early October.
A Briefing Book has been submitted to the FDA to serve as a guide to introduce all major elements of the dossier as well as discuss remaining questions.
Hermann Luebbert, Biofrontera’s chief executive, said: "We are looking forward to the opportunity to discuss our dossier for the combination of Ameluz and BF-RhodoLED with the FDA.
“We are confident that our data package will now satisfy all the requirements for filing.
“Whilst we had hoped for an earlier meeting, this delay will not influence the rest of our time table of filing the final dossier by the end of Q1 2015."
Earlier today, Biofriontera also revealed it was taking legal action against a former supplier, Biosynth, which used to produce one of the main ingredients used in Ameluz.
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