Recro Pharma Inc.: Meloxicam

2019. When you resubmit your application, revise the draft carton and container labeling as follows:

FDA recommends that the human-readable expiration date on the drug package label include a year, month, and non-zero day.

FDA recommends that a hyphen or a space be used to separate the portions of the expiration date.

Act (FDCA), for ANJESO (meloxicam) injection, 30 mg/mL.

1. Although you have demonstrated a statistically significant difference between ANJESO and placebo on the primary endpoint in Studies REC-15-015 and REC-15-016, the results of the secondary analyses, including pain intensity difference over time curves, SPID1824, and SPID42-48, indicate that the analgesic effect does not persist through the dosing interval.

Additionally, the results for time to meaningful pain relief and time to first rescue use indicate a delayed onset of action that is not consistent with expectations for an intravenous analgesic for acute pain, and the frequent use of rescue medication suggests that ANJESO does not provide analgesia suitable to manage postoperative pain.

2. The NDA did not include an adequate extractables/leachables evaluation to justify the safety of potential leachables in the drug product.

Note that the results of the extraction studies should be used to assure that you are adequately monitoring the drug product stability samples for potential leachables from the primary or secondary container closure systems and from your analysis of data from any GOGH manufacturing processes that suggest the potential for additional leachable compounds in the final drug product formulation.

The approach for toxicological evaluation of the safety of leachables must be based on good scientific principles and take into account the drug product formulation, dosage form, route of administration, and dose regimen (chronic or short-term dosing).

With each table, summarize if any of the events were classified as serious, if any treatments were required, and any outcomes for the patients included in each of the tables and/or provide links to this information in the application.

Include the amended PSP in the Complete Response resubmission.