CNS-focused biopharma Axsome Therapeutics has won US Food and Drug Administration (FDA) approval for Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.
This completes a turnaround for the product since May 2022, when Axsome received a Complete Response Letter (CRL) from the FDA regarding its initial New Drug Application (NDA).
The principal reasons given in the CRL related to chemistry, manufacturing, and controls (CMC) considerations. The CRL identified the need for additional CMC data pertaining to the drug product and manufacturing process.
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