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Ad hoc: US regulatory authority gives green light to proposed approach towards approval of Ameluz® and BF-RhodoLED® in the USA


October 8, 2014 - London

Biofrontera AG /Keyword(s): Misc. matters /Ad hoc: US regulatory authority gives green light to proposed approach towards approval of Ameluz® and BF-RhodoLED® in the USA . Ad hoc announcement according to § 15 WpHG. Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

  • All questions raised with the FDA were answered according to the company position
  • Timetable to filing the approval dossier confirmed for end Q1 2015

             

Leverkusen, 08 October 2014 - Biofrontera AG (FSE: B8F), the biopharmaceutical company focusing on skin cancer, has successfully passed another important step towards the approval of Ameluz® and BF-RhodoLED® in the US. In today's pre-NDA (new drug application) meeting with the American Food- and Drug Administration (FDA) all questions raised were answered as proposed by Biofrontera.

Pre-NDA Meetings with the FDA represent the last opportunity for companies prior to submitting a drug approval to exchange positions about the approval pathway and content with the FDA. In preparation of the meeting the FDA typically receives a package containing a summary of the application documentation as well as potential questions along with proposed answers and explanatory background. The application is exceptionally complex in Biofrontera's case as in the US Ameluz® and BF-RhodoLED® have to be approved as combination of a drug and a medical device. Therefore, the Company had raised 12 groups of questions covering regulatory, clinical, preclinical, production and quality aspects.

Due to the high quality of the documentation which Biofrontera had provided in preparation of the meeting, only very few discussion points were left after the preliminary assessment of the FDA. In consequence, the meeting was held as a telephone conference, following a proposal by the FDA. During the discussion the participants reached agreement in all points. Most importantly, no additional studies were requested.

The Company now has green light to proceed according to plan towards approval of Ameluz® and BF-RhodoLED® in the US. The submission of the application is planned by the end of the first quarter 2015.

Biofrontera AG, Hemmelrather Weg 201, 51377 Leverkusen
ISIN: DE0006046113
WKN: 604611

contact: Biofrontera AG
Tel.: +49 (0214) 87 63 2 0, Fax.: +49 (0214) 87 63 290
e-mail: press@biofrontera.com 




This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Biofrontera AG via Globenewswire

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