Vaccines, Blood & Biologics
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March 9, 2012 Approval Letter - GINTUIT
Our STN: BL [125400/0]
Organogenesis Incorporated
Attention: Patrick Bilbo
Vice President of Regulatory Affairs
150 Dan Road
Canton, Massachusetts 02021
Dear Mr. Bilbo:
We are issuing Department of Health and Human Services U.S. License No. 1863 to Organogenesis Incorporated, Canton, Massachusetts under the provisions of section 351(a) of the Public Health Service Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards.
Under this license, you are authorized to manufacture the product Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen. Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen is indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults. Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen is not intended to provide root coverage.
The review of this product was associated with the following National Clinical Trial (NCT) number(s): NCT01547962, NCT00587834, and NCT00679081.
Under this license, you are approved to manufacture Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen at your facility in Canton, Massachusetts. You may label your product with the proprietary name GINTUIT and will market it in 75 millimeter diameter cellular sheets.
The dating period for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen shall be 15 days from the date of manufacture when stored at 20°C-23°C. The date of manufacture shall be defined as the date of primary packaging.
You currently are not required to submit samples of future lots of Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen to the Center for Biologics Evaluation and Research (CBER) for release by the Director, CBER, under 21 CFR 610.2. We will continue to monitor compliance with 21 CFR 610.1 requiring completion of tests for conformity with standards applicable to each product prior to release of each lot.
You must submit information to your biologics license application for our review and written approval under 21 CFR 601.12 for any changes in, including but not limited to, the manufacturing, testing, packaging or labeling of Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen, or in the manufacturing facilities.
You must submit reports of biological product deviations under 21 CFR 600.14. You promptly should identify and investigate all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA-3486 to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.
Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. In addition, please submit three original paper copies for carton and container final printed labeling. All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h.
In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Information on submitting SPL files using eLIST may be found in the draft guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As” at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072392.pdf.
You may submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)).
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).
ADVERSE EVENT REPORTING
You must submit adverse experience reports in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80) and you must submit distribution reports as described in 21 CFR 600.81. You should submit postmarketing adverse experience reports and distribution reports to the Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology HFM-210, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Prominently identify all adverse experience reports as described in 21 CFR 600.80. Per 21 CFR 600.2(f), please refer to http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm106001.htm for updated mailing address information.
In addition, you have agreed to submit adverse event reports for any events in the MedDRA System Organ Class Neoplasms benign, malignant and unspecified (including cysts and polyps), occurring at either the graft site or remote locations, within 15 days after learning of the event, through March 31, 2013.
PEDIATRIC REQUIREMENTS
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 in pediatric patients unless this requirement is waived, deferred, or inapplicable.
We are waiving the pediatric study requirement for children younger than 12 years because necessary studies are impossible or highly impracticable. This is because there are too few children younger than 12 years with mucogingival conditions with insufficient keratinized tissue to study.
We are deferring submission of your pediatric study for ages 12 to 18 years for this application because this product is ready for approval for use in adults and the pediatric study has not been completed.
Your deferred pediatric study required under 505B(a) of the Federal Food, Drug, and Cosmetic Act is a required postmarketing study. The status of this postmarketing study must be reported according to 21 CFR 601.70 and section 505B(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act. This required study is listed below:
- Deferred pediatric study under PREA to assess the safety and effectiveness of Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival disorders in pediatric patients ages 12 to 18 years.
Final Protocol Submission: December 31, 2012
Study Completion Date: September 30, 2016
Final Report Submission: March 31, 2017
Submit the final study report to this BLA. For administrative purposes, all submissions related to this required pediatric postmarketing study must be clearly designated “Required Pediatric Assessment(s).”
AGREED UPON POSTMARKETING COMMITMENTS
We acknowledge your written commitments as described in your letter received March 5, 2012, as outlined below:
Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70.
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We request that you submit information concerning chemistry, manufacturing, and control postmarketing commitments and final reports to your BLA, STN BL 125400.
Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:
- Postmarketing Study Correspondence
- Postmarketing Study Commitment – Final Study Report
- Supplement Contains Postmarketing Study Commitment – Final Study Report
For each postmarketing commitment not subject to the reporting requirements of 21 CFR 610.70, you may report the status to FDA as a “PMC Submission – Status Update.” The status report for each commitment should include:
- The original schedule for the commitment, and
- The status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted).
When you have fulfilled your commitment, submit your final report as PMC Submission – Final Study Report or Supplement Contains Postmarketing Study Commitment – Final Study Report.
Sincerely yours,
Mary A. Malarkey Celia M. Witten, Ph.D., M.D.
Director Director
Office of Compliance and Biologics Quality Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research Center for Biologics Evaluation and Research
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