REMS requires patients to administer Spravato at a clinic in the presence of a physician. “We probably know more about the adverse event profile of intranasal ketamine than, I may argue, any ...
Credit: Johnson & Johnson. The approval of Spravato for the monotherapy indication in TRD was supported by data from the randomized, double-blind, placebo-controlled, phase 4 TRD4005 trial.
TITUSVILLE, N.J., Jan. 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the U.S. Food and Drug Administration (FDA) approval of a supplemental New Drug Application (sNDA ...
We have made great strides in the medical community, with people having access to life-saving physical drugs as well as mental health medicine. A recent approval made by the FDA could be a great step ...
Spravato is classified as a Schedule III controlled substance and is only available through a restricted program called the Spravato REMS. The Food and Drug Administration (FDA) has approved ...
"SPRAVATO ® is now available as a standalone treatment, meaning patients may experience improvements in depressive symptoms as early as 24 hours and at 28 days – without the need for daily oral ...