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FDA Issues Boxed Warning for Denosumab & Approves a Generic NSAID

  |  Issue: April 2024  |  

References

  1. Prolia (denosumab): Drug safety communication—FDA adds boxed warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease. U.S. Food & Drug Administration. 2024 Jan 19.
  2. Biologics license application approval: Prolia (denosumab). U.S. Food & Drug Administration. 2010 Jun 1.
  3. Highlights of prescribing information: Prolia (denosumab). U.S. Food & Drug Administration. 2024 Jan 19.
  4. News release: ANI Pharmaceuticals announces FDA approval and launch of indomethacin oral suspension. ANI Pharmaceuticals Inc. 2024 Jan 16.
  5. Highlights of prescribing information: Indocin (indomethacin) oral suspension. U.S. Food & Drug Administration. 2021 Apr 28.

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