DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Silver Spring MD 20993

NDA 208081
NDA APPROVAL
Biofrontera Bioscience GmbH
c/o Cardinal Health Regulatory Sciences
Attention: Wayne F. Vallee, RPh, RAC
Director, Regulatory Affairs and Product Development
Commerce Plaza II, Suite 300
7400 West 110th St
Overland Park, KS 66210

Dear Mr. Vallee:
Please refer to your New Drug Application (NDA) dated and received July 10, 2015, and your
amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
(FDCA) for Ameluz® (aminolevulinic acid hydrochloride) gel, 10% with BF-RhodoLED® lamp.
This new drug application provides for the use of Ameluz® (aminolevulinic acid hydrochloride)
gel, 10%, in combination with photodynamic therapy (PDT) using BF-RhodoLED® lamp, a
narrowband, red light illumination source, for lesion-directed and field-directed treatment of
actinic keratoses of mild-to-moderate severity on the face and scalp.
We have completed our review of this application, as amended. It is approved, effective on the
date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
CONTENT OF LABELING
As soon as possible, but no later than 14 days from the date of this letter, submit the content of
labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
automated drug registration and listing system (eLIST), as described at
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
of labeling must be identical to the enclosed labeling (text for the package insert and BFRhodoLED User Manual US). Information on submitting SPL files using eLIST may be found
in the guidance for industry SPL Standard for Content of Labeling Technical Qs and As,
available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM072392.pdf.
The SPL will be accessible via publicly available labeling repositories.

Reference ID: 3929378

 NDA 208081
Page 2

CARTON AND IMMEDIATE CONTAINER LABELS
Submit final printed carton and immediate container labels that are identical to the enclosed
carton and immediate container labels as soon as they are available, but no more than 30 days
after they are printed. Please submit these labels electronically according to the guidance for
industry Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical
Product Applications and Related Submissions Using the eCTD Specifications (June 2008).
Alternatively, you may submit 12 paper copies, with 6 of the copies individually mounted on
heavy-weight paper or similar material. For administrative purposes, designate this submission
“Final Printed Carton and Container Labels for approved NDA 208081.” Approval of this
submission by FDA is not required before the labeling is used.
Marketing the product(s) with FPL that is not identical to the approved labeling text may render
the product misbranded and an unapproved new drug.
ADVISORY COMMITTEE
Your application for Ameluz® (aminolevulinic acid hydrochloride) gel, 10% with BFRhodoLED® lamp was not referred to an FDA advisory committee because outside expertise was
not necessary and there were no controversial issues that would benefit from advisory committee
discussion.
REQUIRED PEDIATRIC ASSESSMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
administration are required to contain an assessment of the safety and effectiveness of the
product for the claimed indication(s) in pediatric patients unless this requirement is waived,
deferred, or inapplicable.
We are waiving the pediatric study requirement for this application in patients from birth to 16
years 11 months of age because necessary studies are impossible or highly impractical since the
disease does not occur in children.
PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and promotional
labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
proposed materials in draft or mock-up form with annotated references, and the package insert,
Medication Guide, and patient PI (as applicable) to:

Reference ID: 3929378

 NDA 208081
Page 3

OPDP Regulatory Project Manager

Food and Drug Administration 

Center for Drug Evaluation and Research

Office of Prescription Drug Promotion

5901-B Ammendale Road

Beltsville, MD 20705-1266

Alternatively, you may submit a request for advisory comments electronically in eCTD format.
For more information about submitting promotional materials in eCTD format, see the draft
Guidance for Industry (available at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM443702.pdf ).
As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
2253. Form FDA 2253 is available at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
Information and Instructions for completing the form can be found at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
more information about submission of promotional materials to the Office of Prescription Drug
Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for an approved NDA
(21 CFR 314.80 and 314.81).
If you have any questions, call Belainesh Robnett, Regulatory Health Project Manager, at
(240) 402-4236.
Sincerely,
{See appended electronic signature page}

Kendall A. Marcus, MD
Director
Division of Dermatology and Dental Products
Office of Drug Evaluation III
Center for Drug Evaluation and Research

Enclosures:
Content of Labeling
Carton and Container Labeling

Reference ID: 3929378

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------KENDALL A MARCUS
05/10/2016

Reference ID: 3929378
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