The FDA is considering an application for subcutaneous tanezumab, a monoclonal antibody, as a treatment for moderate to severe osteoarthritis…
FDA Approves Meloxicam Injection & OTC Diclofenac Sodium Topical Gel for Pain Management
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
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
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
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
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 Advisory Committees Reject Oxycodegol (NKTR-181) Application
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
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…
New Gabapentinoid Warning Labels
Gabapentinoid products will now carry warning labels about the risks of respiratory distress when combined with opioids and other nervous system and respiratory depressants…
FDA Action on Loperamide Misuse; Plus Phase 1 Trials for BAT2506 Biosimilar Begin
The FDA has limited the package size of some over-the-counter loperamide products to prevent its potential misuse and abuse…
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