B. Braun Medical, Inc.: Acetaminophen

October 24, 2019. We reserve our comments on the acceptability of the packaging labels for the next review cycle.

We refer to the following deficiency communicated to you in our March 27, 2019, complete response (CR) letter and in further detail in our March 25, 2019, information request letter that preceded the CR letter: "Provide updated letters from Mallinckrodt that clearly indicate a specific date upon which your application can be approved."

"update consent approval"), clearly indicating a specific date (October 12, 2018) upon which our application can be approved are provided in Module 1.3.5.2." We note that legal review of these updated letters is still pending at this time and therefore we have not made a determination as to whether this is still deficient.

Act (FDCA) for Acetaminophen Injection in the PAB Container, 500 mg/50 mL and 1000 mg/100 mL.

Satisfactory resolution of the observations is required before this application may be approved.

Thus, revise the NDC numbers so that the carton labeling and vial labels use a different NDC package code (last 2 digits of the NDC).

We have the following comments/recommendations that are not approvability issues, however, they should be addressed in your complete response to this action:

Act for Acetaminophen Injection in the PAB Container, 500 mg/50 mL and 1000 mg/100 mL.

During a recent inspection of the B. Braun Medical, Inc. manufacturing facility (FEI 2021236), our field investigator observed product specific and GMP compliance issues at the facility and conveyed that information to the representative of the facility at the close of the inspection.

We have the following comments and recommendations that are not approvability issues that should be addressed prior to a subsequent NDA resubmission:

1. Tighten the drug product specification for 4-aminophenol and 4-nitrophenol based on long-term stability data to as low as technically feasible.

FDA-approved products that use the same container closure system or conduct an adequately designed 14-day toxicology study that identifies a NOAEL that establishes adequate safety margins.