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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
August 31, 2001
Our STN Number: BL 103910/0
Ms. Carol P. Clark-Evans
Protherics Inc.
(a wholly-owned subsidiary of Protherics PLC)
1207 17th Avenue S., Suite 103
Nashville, TN 37212
Dear Ms. Clark-Evans:
Your Biologics License Application for Digoxin Immune Fab (Ovine), for the treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose, is approved effective this date. Protherics Inc. (a wholly-owned subsidiary of Protherics PLC) is hereby authorized to introduce or deliver for introduction into interstate commerce Digoxin Immune Fab (Ovine), manufactured at Protherics Inc. (a wholly-owned subsidiary of Protherics PLC) under U.S. License No. 1575.
Under this license you are authorized to introduce or deliver for introduction into interstate commerce Digoxin Immune Fab (Ovine), in a -------------------------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------.
Under this authorization, you are approved to manufacture Digoxin Immune Fab (Ovine) drug substance at your Wales, United Kingdom facility, and drug product, including filling and packaging, at your contract facility --------------------------------------------------------------. Changes to the product, production process, location of production process, equipment, facilities, or responsible personnel are required to be reported to FDA as specified in Title 21 Code of Federal Regulations (CFR) Section 601.12.
The dating period for this product shall be 36 months from the date of manufacture when stored at 2-8 °C. The date of manufacture shall be defined as the date of the initial sterile filtration of the formulated bulk.
We acknowledge the following actions you have committed to take following licensure of Digoxin Immune Fab (Ovine):
- To continue the stability studies for lots -------------------------------------------- through 36 months, and submit the results of testing to CBER, for each lot, as the data becomes available.
- To provide---------------study data to validate the---------------for processing of the 10ml size vials.
- To re-evaluate the----------------------------------------------------------------------------------and to revise the definitive protocol for finished product testing, if appropriate.
- To review and adjust by appropriate submission to the FDA the------------------------------------- based on data from a total of 10 batches, and during the interim period to place any batch produced with a -------------- content at release of greater than----------will be placed on real-time and accelerated stability studies.
All adverse reports should be submitted according to 21 CFR 600.80 to the Center for Biologics Evaluation and Research (CBER), HFM-210, Food and Drug Administration, 1401 Rockville Pike, Rockville, Maryland 20852-1448. In addition, safety related information obtained in the course of other relevant clinical studies should be reported in accordance with 21 CFR 312.32. It is also requested that distribution reports be submitted according to 21 CFR 600.81.
Please submit three (3) copies of final printed labeling at the time of use accompanied by Part II of FDA Form 2567 with completed implementation information. In addition, you may wish to submit your proposed introductory advertising and promotional campaign. If so, please submit three (3) copies of the proposed material in draft form with Part I of the FDA Form 2567/2253 to CBER, Advertising and Promotional Labeling Branch (APLB), HFM-602, 1401 Rockville Pike, Rockville, Maryland 20852-1448. Promotional claims should be consistent with and not contrary to the approved labeling. No comparative claims or claims of superiority over other similar products should be made unless data to support such claims are submitted to and approved by the Center for Biologics Evaluation and Research. Final copies of advertising and promotional materials should be submitted at the time of use with Part II of FDA Form 2567/2253 to APLB. Please include copies of the approved labeling with your proposed or final copy of advertising and promotional materials submitted to CBER.
It is recommended that a copy of this letter be available for review at the time of FDA inspections.
Sincerely yours,
--- signature ---
Jay S. Epstein, M.D.
Director
Office of Blood Research and Review
Center for Biologics Evaluation
and Research
Sincerely yours,
--- signature ---
Steven A Masiello
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
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