Incomplete Response to CR Letter - Intersol
Our STN: BN 080041/0
Attention: Mr. Matthew Nowland
Three Corporate Drive
Lake Zurich, IL 60047
Dear Mr. Nowland:
We have received your May 12, 2009 amendment to your new drug application (NDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for InterSol Solution, for the storage of Amicus-derived apheresis platelets for up to 5 days.
We have determined that your amendment does not completely respond to our April 6, 2009 complete response letter. We stopped the review clock when we issued our complete response letter. Because your responding amendment is incomplete, we will not restart the clock until you address all the following deficiencies:
Fenwal's response to item 29 (Compliance), in the April 6, 2009 complete response letter, refers FDA to the sponsor's February 20, 2009 reply to Form FDA 483. Pertaining to item 'A' on Filter validation activities, which raised concerns about the filter compatibility with the PAS III solution or effect of the solution on the filter and concern about the leachables/extractables which may be harmful to the patient, Fenwal states, on page 4 of 6 of its February 20, 2009 document, that a closing report will be revised to include the Filter test requirements summary as well as the required clarification to explain why the extractable results for the filter were not included as part of the protocol documentation. The lack of this significant information in Fenwal's May 12, 2009 response renders it incomplete.
If you have any questions, please contact the Regulatory Project Manager, Heather Erdman, at (301) 827-6182.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research