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The purpose of the study was to combine the advantages of self-nanoemulsifying drug delivery systems and tablets as a conventional dosage form. Self-nanoemulsifying drug delivery system (SNEDDS) was ...
The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...
The CAPS-5 total score ranks severity of 20 PTSD symptoms from 0 (not present) to 80 (most severe). Baseline values for the ...
The U.S. Food and Drug Administration's reviewers on Wednesday raised efficacy concerns over the use of Otsuka Pharma's drug in combination with Viatris' Zoloft for the treatment of adults with PTSD.
The Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted 10-1 against the approval of brexpiprazole in combination with sertraline for the treatment of adults ...
An FDA advisory panel concludes that the efficacy of brexpiprazole, when started concurrently with sertraline, has not been ...
The prospect of Lundbeck and Otsuka’s Rexulti becoming part of a new treatment for post-traumatic stress disorder (PTSD) ...
The Food and Drug Administration is considering adding warning labels to antidepressants for women who are pregnant, despite ...
A U.S. Food and Drug Administration (FDA) advisory panel has voted overwhelmingly against the approval of Otsuka ...
The FDA is raising efficacy questions over Lundbeck and Otsuka’s proposed combination of their Rexulti with Viatris’ Zoloft ...
On Monday morning, the FDA hosted a 10-person expert panel on the use during pregnancy of SSRIs, which include medications ...
SSRIs are linked to a condition called neonatal adaption syndrome, in which infants are born jittery, irritable and with abnormal muscle tone. About one-third of infants born to mothers taking SSRIs ...