Ever wonder what role physician regulators—rheumatologists, in particular—perform at the U.S. Food & Drug Administration (FDA)? “I am not sure that many practicing rheumatologists know there are clinicians who work for the FDA,” says rheumatologist Nadia Habal, MD, a medical officer in the Division of Pulmonary, Allergy, and Rheumatology Products at the FDA. “It would…
The FDA has approved two pain medications: meloxicam in an injection and over-the-counter diclofenac sodium topical gel 1%…
On April 7, the FDA approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200 mg, for the treatment of: 1) uncomplicated malaria due to P. falciparum, P. malariae, P. ovale and P. vivax; 2) chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and 3) treatment of acute and chronic…
The FDA has authorized a phase 3 clinical trial examining the safety and efficacy of tocilizumab plus standard care in patients hospitalized with COVID-19…
April 1 (Reuters)—The U.S. Food and Drug Administration (FDA) said malaria drugs hydroxychloroquine and related chloroquine are in shortage due to a surge in demand because of the coronavirus pandemic. The drugs, which have been tried with some success to treat the illness caused by the virus, were added to the agency’s website that lists…
March 23 (Reuters)—Roche Holding AG said on Monday it has received the U.S. Food and Drug Administration‘s clearance to test its rheumatoid arthritis treatment on patients hospitalized with severe pneumonia caused by the coronavirus. The company said it was beginning a late-stage study to test the drug in what would be the first well-controlled study…
ATLANTA—New drug approvals, new and expanded drug indications, and important safety and other updates relevant for rheumatologists were presented by three physicians from the U.S. Food & Drug Administration (FDA) on Nov. 11 at the 2019 ACR/ARP Annual Meeting. New JAK Inhibitor Approved for RA On Aug. 16, 2019, the FDA approved upadacitinib (Rinvoq), an…
FDA advisory committees rejected the new drug application for oxycodegol, an opioid analgesic, due to a lack of data regarding it’s potential for abuse…
Last year, the FDA was busy with new biologic and other drug approvals, new and expanded drug indications, and important safety updates relevant to rheumatology…
Upadacitinib will soon be available to treat patients with moderate to severe rheumatoid arthritis in Canada and the E.U…