The U.S. Food and Drug Administration issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.
The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed.
Genentech, a member of the Roche Group announced the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous Actemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.
Biocon Ltd. and Mylan N.V. announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin® (bevacizumab), for review under the 351(k) pathway.
The U.S. Food and Drug Administration has approved an application for the first generic of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide (a group of medicines used to treat bacterial infections).
U.S. Food and Drug Administration took additional steps to ensure a smooth regulatory transition aimed at increasing patient access to insulin products used daily by millions of Americans to maintain stable blood glucose levels, as well as certain other biological products set to transition regulatory pathways in March. Today’s actions include publishing a final rule and additional resources to provide useful information to stakeholders, including industry, patients and health care providers.
The U.S. Food and Drug Administration authorized marketing of the first test to detect a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual disability. The test is intended as an aid in diagnosing FXS and is to be used along with the evaluation of a patient’s family history and clinical signs and symptoms of FXS. Additionally, this test is intended for use in adults who may be carriers of genetic alterations in the gene associated with FXS, called the FMR1 gene.
The U.S. Food and Drug Administration today approved three drugs for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary relief of arthritis pain; Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander; and Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%) for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander, for nonprescription use.