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FDA Approves Xifyrm

FDA Approves Xifyrm (meloxicam) Injection for the Management of Moderate-to-Severe Pain in Adults

Woburn, MA — June 10, 2025 — Azurity Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Xifyrm (meloxicam injection) an IV non-steroidal anti-inflammatory drug (NSAID) that offers once daily dosing.

Xifyrm is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. Xifyrm provides a non-opioid analgesic in a 30mg/mL vial for IV bolus injection over 15 seconds. Because of delayed onset of analgesia, Xifyrm alone is not recommended for use when rapid onset of analgesia is required.

“Xifyrm demonstrates our commitment to improving patient care by providing an alternate dosage form for pain management,” said Ron Scarboro, CEO at Azurity Pharmaceuticals. “Xifyrm addresses an important clinical need, especially for patients requiring a non-opioid component to multimodal analgesia strategies.”

Xifyrm will be available in the coming weeks. For full prescribing information, including boxed warning and safety profile, please visit www.Xifyrm.com

About Azurity Pharmaceuticals

Azurity Pharmaceuticals is a privately held company committed to delivering innovative, high-quality medicines for overlooked patients. Azurity’s global footprint is over 50 countries, with a diversified portfolio of 30+ marketed brands spanning ten dosage forms and ten key therapeutic areas. Powered by its Next-Gen Commercial Model, Azurity leverages data, analytics, and AI-driven digital tools to enhance market reach and stakeholder engagement. Our medicines have benefited millions of people. For more information, visit www.azurity.com.

Source: Azurity Pharmaceuticals, Inc.

Xifyrm (meloxicam) FDA Approval History

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