ResQ Pharma: NDA 217382

Based on the subjective feedback and root cause analyses from the HF validation study, we determine that you will need to develop and implement additional risk controls, including risk controls that consider both device design and relevant labels and labeling, in order to address the identified use issues and reduce the risk of associated medication errors.

The safety update should include data from all nonclinical and clinical studies/trials of the drug product under consideration regardless of indication, dosage form, or dose level.

It appears that more than half of the 138 reports (that did not use lipid emulsion therapy for treatment of LAST) are over 20 years old, whereas the first reported use of lipid emulsion therapy for a patient experiencing LAST was around 2006.

We also note that given the paucity of literature references provided that definitively administered Intralipid for the treatment of LAST in pediatric patients, you will need to provide additional justification why the available data are adequate to support all aspects of labeling, including the recommended dosing regimen, in pediatric patients of all age groups.

Your proposed prescribing information was not fully reviewed during this review cycle due to the Complete Response action.

Specifically, the proposed prescribing information for oe lists the following indication: oe 20%, a soybean oil emulsion indicated as a treatment for local anesthetic systemic toxicity (LAST).

In your NDA resubmission, clarify what indication you are seeking, and specifically, whether you intend to limit the indication to treatment of LAST resulting from certain local anesthetics versus treatment of LAST resulting from any local anesthetic.

If, however, repeat bolus is required and the infusion rate is doubled (as recommended in your proposed prescribing information) because response is not achieved with the first bolus and infusion, then the maximum treatment duration would be approximately 14 minutes prior to reaching the maximum recommended dose.

In your NDA resubmission, provide recommendations on additional treatment options if the maximum dose of | has been administered with no effect.