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FDA Rheumatology Update: New Drug Approvals, Plus Expanded Drug Indications & Safety Concerns

Susan Bernstein  |  February 12, 2020


Susan Bernstein is a freelance journalist based in Atlanta.

References

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  1. U.S. Food & Drug Administration. Drug approvals and databases: Drug trials dnapshots: RINVOQ. 2020 Jan 21.
  2. White WB, Saag KG, Becker MA, et al. Cardiovascular safety of febuxostat or allopurinol in patients with gout. New Engl J Med. 2018 Mar 29;378(13):1200–1210.
  3. U.S. Food & Drug Administration. Drug safety and availability: FDA approves boxed warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR): FDA drug safety communication. 2019 Aug 28.
  4. Hinze C, Gohar F, Foell D. Management of juvenile idiopathic arthritis: Hitting the target. Nat Rev Rheumatol. 2015 May;11(5):290–300.
  5. Pottackal G, Travis J, Neuner R, et al. Application of bayesian statistics to support approval of intravenous belimumab in children with systemic lupus erythematosus in the United States (abstract #2865). Arthritis Rheumatol. 2019 Oct;71(suppl 10).

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Filed under:Drug Updates Tagged with:2019 ACR/ARP Annual MeetingBiologicsFDAU.S. Food and Drug Administration (FDA)

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