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April 2, 2010 Approval Letter - TachoSil
Our STN: BL 125351/0
Nycomed Danmark ApS
Attention: Ms. Camilla Wamberg
Dear Ms. Wamberg:
We are issuing Department of Health and Human Services U.S. License No. 1825 to Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark, 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 Fibrin Sealant Patch. Fibrin Sealant Patch is indicated for use as an adjunct to hemostasis in cardiovascular surgery when control of bleeding by standard surgical techniques, such as suture, ligature or cautery, is ineffective or impractical.
Under this license, you are approved to manufacture Fibrin Sealant Patch at your facility in 25 St. Peter Strasse, Linz A-4020, Austria. You may label your product with the proprietary name TachoSil and market it in 9.5cm x 4.8cm, 4.8cm x 4.8cm and 3.0cm x 2.5cm sizes.
We did not refer your application to the Blood Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an Advisory Committee discussion.
The dating period for Fibrin Sealant Patch shall be 24 months from the date of manufacture when stored at 5 oC ± 3 oC. The date of manufacture shall be defined as the date of gamma irradiation of the packaged fibrin sealant patch. The dating period for your drug substances shall be ----------(b)(4)--- from the date of manufacture when stored at ---(b)(4)----- The expiration date for the packaged product, TachoSil, shall be dependent on the shortest expiration dates of the human fibrinogen or human thrombin components.
Please submit final container samples of the product in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologic Evaluation and Research (CBER).
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 Fibrin Sealant Patch, 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 submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate. Please provide content of labeling in Structured Product Labeling format. Please provide a PDF-format electronic copy as well as three original paper copies for all labels other than the package insert.
In addition, you may wish to 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.
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.
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 deferring submission of your pediatric study until December 2010 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 for use of TachoSil as an adjunct to hemostasis in pediatric patients 0-16 years undergoing hepatic resection surgery.
- Final Report Submission: December 2012
Submit final study reports to this BLA. For administrative purposes, all submissions related to this required pediatric postmarketing study must be clearly designated “Required Pediatric Assessment”.
Mary A. Malarkey
Office of Compliance and
Center for Biologics
Evaluation and Research
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics
Evaluation and Research