• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

December 9, 2009 Approval Letter - InterSol

Our Reference:  NDA BN080041/0

Fenwal, Inc.
Attention: Dr. Cheryl Chamberlain Roscher
Three Corporate Drive
Lake Zurich, IL  60047

Dear Dr. Roscher:

Please refer to your new drug application (NDA) dated July 31, 2008, received August 4, 2008, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act, for InterSol Solution, 500mL solution in non-PVC PL 2411 plastic container.

We acknowledge receipt of your submissions dated October 10 and 22, December 17, 23 and 29, 2008, and January 9 and 23, February 12, 13, and 20, March 10, 11, and 18, April 13 and 21, May 12, June 5, 11, 21, 30, and 31, August 7 and 13, September 3, 4, 10, 15, 17, 22, 25 and 30, October 6, 9, and 29, November 4 and 12, and December 1, 2009.

We also acknowledge receipt of your submission dated June 11, 2009.  The June 11, 2009 submission constituted a complete response to our April 6, 2009 action letter.

This new drug application provides for the use of InterSol Solution, 500mL platelet additive solution 3 (PAS 3) for the storage of Amicus-derived apheresis platelets in 65% InterSol / 35% plasma for up to five days.

We have completed our review of this application, as amended.  It is approved, effective on the date of this letter, for use as recommended in the content of labeling [21 CFR 314.50(1)] in structured product labeling (SPL) format submitted on October 6, 2009.

PEDIATRIC RESEARCH EQUITY ACT (PREA):

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(s) in pediatric patients unless this requirement is waived, deferred, or inapplicable.  This application does not trigger PREA.

POSTMARKETING REQUIREMENTS UNDER 505(o):

Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require holders of approved drug and biological product applications to conduct postmarketing studies and clinical trials for certain purposes, if FDA makes certain findings required by statute (section 505(o)(3)(A)).

Therefore, based on appropriate scientific data, FDA has determined that you are required to conduct the following:

1.   Track Adverse Event Rate

      You have committed to conduct a controlled post marketing study to track adverse events in the recipients of Amicus platelets stored in 65% InterSol / 35% plasma.  Adverse events (e.g. transfusion reactions) will be captured through active surveillance of the test and the control products.  Transfusion reactions will be classified and compared by type (e.g. TRALI, febrile non-hemolytic transfusion reaction, allergic reaction, etc.).  Fenwal will conduct the postmarketing requirement at select institutions that are currently transfusing AMICUS platelets in plasma and are planning to switch over to AMICUS InterSol platelets.

      A complete statistical plan including hypothesis testing will be submitted with the final protocol.

      We acknowledge the timetable you submitted on November 12, 2009, which states that you will conduct this trial according to the following schedule:

Protocol Submission:        Within 2 months after NDA approval and 510(k) clearance

Study Start:                       Within 3 months of FDA’s acceptance of the final protocol

Final Report Submission:  Within 17 months of initiation of the study

Submit all final report(s) to this NDA.  Prominently identify the submissions with the following wording in bold capital letters at the top of the first page of the submission, as appropriate:

  •          REQUIRED POSTMARKETING INTERIM REPORT UNDER 505(o)
  •          REQUIRED POSTMARKETING FINAL REPORT UNDER 505(o)
  •          REQUIRED POSTMARKETING CORRESPONDENCE UNDER 505(o)

Section 505(o)(3)(E)(ii) of the FDCA requires you to report periodically on the status of any study or clinical trial required under this section.  This section also requires you to periodically report to FDA on the status of any study or clinical trial otherwise undertaken to investigate a safety issue.  Section 506B of the FDCA, as well as 21 CFR 314.81(b)(2)(vii) requires you to report annually on the status of any postmarketing commitments or required studies or clinical trials.

FDA will consider the submission of your annual report under section 506B and 21 CFR 314.81(b)(2)(vii) to satisfy the periodic reporting requirement under section 505(o)(3)(E)(ii) provided that you include the elements listed in 505(o) and 21 CFR 314.81(b)(2)(vii).  We remind you that to comply with 505(o), your annual report must also include a report on the status of any study or clinical trial otherwise undertaken to investigate a safety issue.  Failure to submit an annual report for studies or clinical trials required under 505(o) on the date required will be considered a violation of FDCA section 505(o)(3)(E)(ii) and could result in enforcement action.

POSTMARKETING COMMITMENT NOT SUBJECT TO REPORTING REQUIREMENTS OF SECTION 506B:

We acknowledge your commitment, submitted on November 12, 2009, to conduct a postmarketing study.  This commitment is listed below.

 

2.   ---(b)(4)-----

 

------------(b)(4)--------------------------------------------------------------------------------------------------------------------
-------------------------------

 

---------(b)(4)-----------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)----------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------
--------------

----------------------(b)(4)----------------------------------------------------------------------

----------------------(b)(4)----------------------------------------------------------------------

----------------------(b)(4)--------------------------------------------------

Submit clinical protocols to your IND for this product.  Submit nonclinical and chemistry, manufacturing, and controls protocols and all study final reports to this NDA.  In addition, under 21 CFR 314.81(b)(2)(vii) and 314.81(b)(2)(viii), you should include a status summary of each commitment in your annual report to this NDA.  The status summary should include expected summary completion and final report submission dates, any changes in plans since the last annual report, and, for clinical studies, number of patients entered into each study.  All submissions, including supplements, relating to these postmarketing study commitment and requirement should be prominently labeled “Postmarketing Study Commitment Protocol”, “Postmarketing Study Commitment Final Report”, or “Postmarketing Study Commitment Correspondence.”

PROPRIETARY NAME:

We have considered your proposed proprietary name, InterSol Solution, in consultation with CBER’s Advertising and Promotional Labeling Branch and conclude that under 21 CFR Part 201 the proposed proprietary name InterSol Solution is acceptable at this time.

REPORTING REQUIREMENTS:

We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81).  All 15-day alert reports, periodic (including quarterly) adverse drug experience reports, field alerts, annual reports, supplements, and other submissions should be addressed to the original NDA BN080041 for this drug product. 

If you have any questions, please contact the Regulatory Project Manager, Heather Erdman, at (301) 827-6182.

Sincerely yours,

 

Jay S. Epstein, M.D.
Director
Office of Blood Research and Review
Center for Biologics
  Evaluation and Research