FDA Sends Second Complete Response Letter for Intravenous Meloxicam
The U.S. Food and Drug Administration (FDA) has sent a second complete response letter to Recro Pharma regarding the new drug application for intravenous (IV) meloxicam. The treatment is designed to manage moderate to severe pain.1
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The letter cited the onset and duration of IV meloxicam as concerns, noting that the delayed onset fails to meet the prescriber expectations for IV drugs. The letter also cited regulatory concerns about the role of IV meloxicam as a monotherapy for acute pain, as well as how it would meet patient and prescriber needs in that setting.
Recro Pharma intends to continue to pursue regulatory approval for IV meloxicam. The manufacturer was disappointed by the letter and is dedicated to bringing IV meloxicam and other non-opioid pain products to market. Recro Pharma will work closely with the FDA to determine the best path forward.