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# Baudax Bio NDA for Anjeso Approved
- URL: https://www.fdaweb.com/baudax-bio-nda-for-anjeso-approved/
- Published: 2020-02-20T12:00:00.000Z
- Updated: 2026-09-14T16:03:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146138

FDA has approved a Baudax Bio NDA for Anjeso (meloxicam injection), indicated for managing moderate to severe pain, alone or in combination with other analgesics. The product is intended to be administered as a once-a-day intravenous bolus push. The active ingredient meloxicam is a long-acting, preferential COX-2 inhibitor. The company says Anjeso was developed for the unmet need for non-opioid options in pain treatment.

Approval was based on data from two Phase 3 efficacy studies and one double-blind, placebo-controlled Phase 3 safety study. The most common adverse reactions reported included constipation and anemia.