HQ Specialty Pharma Corporation: Meropenem

November 16, 2020, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA), for Meropenem for Injection" 2 g/vial.

However, the FDA recommends 5 mcg/day as the qualification threshold for non-genotoxic leachables.

Conduct and provide results of a study to justify the proposed overfill and to demonstrate that the labeled drug amount can be consistently withdrawn from the vial according to the labeling reconstitution instructions.

We also acknowledge receipt of your amendment dated December 6, 2019, which was not reviewed for this action.

Comments regarding the characterization data in Annex 2 of your submission dated October 15, 2019 are listed below:

® (Annex 2, submission dated October 15, 2019).

Study Via Intravenous Injection in Sprague Dawley Rats with 14-Day Recovery," assessing the difference in the safety profiles of potential leachates from the stopper on December 6, 2019. This amendment was not reviewed as the report was provided late in the review cycle.

As stated above, you may reference this submission in any resubmission to this NDA.

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

Federal Food, Drug, and Cosmetic Act for Cefazolin for Injection USP, 2 g/vial.

In your response dated September 14, 2018, you confirmed that the program used in the leachables study erroneously provided the CAS numbers, and that both leachables do not have CAS numbers.

5. No characterization data or descriptions of laboratory studies demonstrating efforts to identify the structures were submitted for the specified unidentified impurities in the drug product specifications.

Submit the characterization data for the unidentified specified impurities above the identification threshold in the drug product specifications.

The analytical methods should be validated for the measurement of the specified impurities in the drug product specifications.

Submit draft carton and container labeling revised as follows:

Additionally, we request that you add the product barcode to the carton labeling.

For example, "...equivalent to 2 grams of cefazolin."

OO Tn your complete response, please address your plans for pediatric assessment.