Xspray Pharma AB: nilotinib

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on FDA 483 prior to your complete response.

Following resolution of the CGMP inspection, FDA may need to conduct a pre-approval inspection (PAI) of the facility.

Thus, we are concerned that your proposed nomenclature would create confusion and would not have the intended effect of mitigating the risk of medication errors associated with switching between your proposed dasatinib product and an approved dasatinib product and safe treatment initiation with your proposed dasatinib product.

Below are two possible actions that you may consider to place your application in condition for approval:

We recommend that you request a meeting with the Agency to discuss your plans on reformulation, the design of any new label comprehension studies, or another proposed approach that would allow for the safe use of © for the proposed indications.

As the applicant, we do not expect a response to this facility-related deficiency when responding to any other deficiencies cited in this or other information request or discipline review letters.

The labeling comprehension studies showed the risk mitigation strategy of adding a descriptor like oe " after oe (dasatinib tablets)' did not prevent medication errors when the currently proposed package insert is used.

We also highly recommend that you request a meeting with the Agency prior to initiating additional studies evaluating other risk mitigation strategies.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response resubmission.

FDA Form 483. If the FDA determines the deficiencies resolved following a full review of the inspection and 483 responses after this Complete Response Letter, the facility will be informed.