
Classification as Major Amendment - RECOTHROM

 
 
M E M O R A N D U M

Department of Health and Human Services
 Public Health Service
 Food and Drug Administration
 Center for Biologics Evaluation and Research

Date: 7 August 2007 

To: Mark Shields & File of STN 125248 

From: Roman Drews, HFM-392 

Through: Timothy Lee, HFM-392
 Acting Chief, Laboratory of Hemostasis/DH/OBRR 

Subject: Classification as Major Amendment of ZymoGenetics, Inc's submission to their Biologics License Application for Thrombin (Recombinant) 

This memorandum summarizes our decision to classify as a Major Amendment ZymoGenetics Inc's (ZGI's) submission to their biologics license application (BLA) for Thrombin (Recombinant). ZGI submitted this amendment as a partial response to CBER's information request dated June 22, 2007. The submission reached CBER on August 2, 2007, within 3 months of the action due date of the BLA. Additional information will be provided in the next two weeks. The current amendment contains 2000 pages of new information on analytical testing, manufacturing and facility, which are not previously reviewed by the Agency. Specifically, ZGI has provided:
•New data regarding the qualification of Master Cell Bank, and control, validation and operation of -----
 --------------- and chromatography columns
•New validation data for analytical methods used to release drug substance and final drug product, and justifications for the proposed specification acceptance limits
•New data regarding the proposed controls of the manufacturing process
•New data for the validation of the manufacturing process including sterilization of equipment and qualification of lyophilization and filling operations
•New data regarding production records for multiple manufacturing steps

Because of the above reasons, this submission qualifies as a major amendment to the original BLA under PDUFA III in accordance with CBER SOPP 8402. Therefore, we will add an additional three (3) months to the time by which we should complete our review. The action due date is now 18 January 2008.
