Par Sterile Products, LLC: Micafungin

Food, Drug, and Cosmetic Act for Micafungin for Injection, 50 mg/vial and 100 mg/vial.

We also acknowledge receipt of your amendment dated April 6, 2020, which was not reviewed for this action.

5% dextrose diluted admixture of 100 mg drug product as shown in Table 7-4 on page 126 of 134. The assay value of mg/mL is more than )%% off from the target 0.5 mg/mL concentration and this could affect the efficacy of the drug product.

After determining the cause and correcting, reconduct the assay test of the in-use-stability study to support labeling.

2. Regarding the drug product specification:

31, 2020. The adequacy of your revised leachables study will be assessed at time of resubmission.

An inspection of the © facility is required before the application can be approved as the FDA must assess the ability of that facility to conduct the listed manufacturing operations in compliance with CGMP.

You may respond to the other deficiencies in this Complete Response letter while the travel restrictions remain in effect.

However, even if all other deficiencies are addressed, the application cannot be approved until the required FDA inspection is conducted and the findings are assessed with regard to your application.

1. We note that) 998 for the drug substance in the drug product composition.

3. Regarding the assay method for Micafungin Sodium in Drug Product:

4. With respect to your response to Deficiency #2 and the related substance method (MET-00698) dated November 22, 2019: