Product Approval Information - Licensing Action
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448
November 4, 2005
U.S. License Number: 1702
ATTN: Mr. Michael Campbell
Olympus America Inc.
3131 West Royal Lane
Irving, TX 75063-3104
Dear Mr. Campbell:
In our July 26, 2005 biologics license applications approval letter for the Blood Grouping Reagents and Anti-Human Globulin listed below, the dating period was stated to be 18 months from the date of manufacture and the date of manufacture was defined as the date of filtration.
Upon review of the approval letter, you notified us on behalf of Biotest AG, that the date of manufacture defined in our letter was not consistent with the information in the BLA submission. Based on the information in the submission and your clarifications we are issuing the following corrections.
For the Blood Grouping Reagents listed in the table below, the dating period shall be 18 months from the date of filling, i.e., the dispensing of the reagents into the microwells. Please note that this represents an exception to 21 CFR 610.50(a), 21 CFR 610.53, and 21 CFR 660.21(e) which define the date of manufacture and the dating period.
|STNs: BL||Product Proper Name||Clone ID||Proprietary Name|
|125094/0||Blood Grouping Reagent,|
Anti-A (Murine Monoclonal)
|A003||Component of Erytype S|
|125095/0||Blood Grouping Reagent,|
Anti-B (Murine Monoclonal)
|B005||Component of Erytype S|
|125096/0||Blood Grouping Reagent,|
Anti-A,B (Murine Monoclonal Blend)
|Component of Erytype S|
|125097/0||Blood Grouping Reagent,|
Anti-D (Monoclonal) (IgM)
|Component of Erytype S|
For the Anti-Human Globulin listed below, the dating period shall be 18 months from the date of the last valid potency test consistent with 21 CFR 610.50(a) and 21 CFR 660.51(e). Please note that this represents an exception to 21 CFR 610.53 that states the dating period shall be 2 years.
|STN: BL||Product Proper Name||Proprietary Name|
|125098/0||Anti-Human Globulin, Anti-IgG (Rabbit)||Anti-Human Globulin Solidscreen II|
We regret any inconvenience these errors have caused.
This information has been placed in your biologics license file. Please keep a copy of this letter available for review at the time of FDA inspections.
--- signature ---
Alan E. Williams, Ph.D.
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics Evaluation and Research