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Articles tagged with "U.S. Food and Drug Administration (FDA)"

FDA Approves Meloxicam Injection & OTC Diclofenac Sodium Topical Gel for Pain Management

Michele B. Kaufman, PharmD, BCGP  |  April 13, 2020

The FDA has approved two pain medications: meloxicam in an injection and over-the-counter diclofenac sodium topical gel 1%…

FDA Accelerates Approvals of Generic Versions of HCQ

U.S. Food and Drug Administration  |  April 8, 2020

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…

Tocilizumab Begins Clinical Trial for COVID-19

Michele B. Kaufman, PharmD, BCGP  |  April 7, 2020

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…

U.S. FDA Says HCQ & Other Malaria Drugs in Shortage as COVID-19 Drives Up Demand

Reuters Staff  |  April 1, 2020

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…

Roche Gets FDA Nod for Trial to Test Arthritis Drug on COVID-19 Patients

Reuters Staff  |  March 25, 2020

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…

FDA Update: New Drug Approvals, New & Expanded Indications, & More

Susan Bernstein  |  March 12, 2020

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 Reject Oxycodegol (NKTR-181) Application

Michele B. Kaufman, PharmD, BCGP  |  February 19, 2020

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…

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

Susan Bernstein  |  February 12, 2020

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…

Canada & E.U. Approve Upadacitinib for RA

Michele B. Kaufman, PharmD, BCGP  |  January 28, 2020

Upadacitinib will soon be available to treat patients with moderate to severe rheumatoid arthritis in Canada and the E.U…

New Gabapentinoid Warning Labels

Michele B. Kaufman, PharmD, BCGP  |  January 23, 2020

Gabapentinoid products will now carry warning labels about the risks of respiratory distress when combined with opioids and other nervous system and respiratory depressants…

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