Posted by Michael Wonder on 31 Oct 2019
FDA grants appeal to Recro Pharma for IV meloxicam new drug application
31 October 2019 - Received positive response from FDA regarding IV meloxicam formal dispute resolution request.
Recro Pharma today announced that it has received a written decision from the U.S. Food and Drug Administration (FDA) granting its appeal of the Complete Response Letter relating to the New Drug Application (NDA) seeking approval for intravenous (IV) meloxicam.
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.”
