FDA grants appeal for N 1539 complete response for treatment of moderate to severe pain.- Recro Pharma

Recro Pharma announced that it has received a written decision from the FDA granting its appeal of the Complete Response Letter relating to the New Drug Application (NDA) seeking approval for N 1539 (meloxicam IV). The FDA�s letter states that the appeal was granted �specific to the request�that the NDA provides sufficient evidence of effectiveness and safety to support approval.�

The letter also states that �before IV meloxicam can be approved and legally marketed, agreed-upon labeling (prescribing information) must be negotiated with the Division.� The Company is now in the process of preparing a comprehensive response to the FDA that includes proposed labeling that aligns with the FDA guidance received in the written decision letter and provides the relevant evidence from the filed NDA to ensure safe and effective use of IV meloxicam by prescribers.

Comment: In March 2019 Recro Pharma received a second Complete Response Letter (CRL) from the FDA Office of Drug Evaluation II regarding their New Drug Application (NDA) seeking approval for intravenous (IV) meloxicam for the management of moderate to severe pain.