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In February 2022, AbbVie requested approval by the US Food and Drug Administration (FDA) for adjunctive treatment for major depressive disorder. [43] Approval was granted by the FDA in December 2022 for cariprazine to be used as an adjunctive treatment for major depressive disorder. [44]
In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [2]
In 2005, the FDA issued an advisory warning of an increased risk of death when atypical antipsychotics are used in dementia. [47] In the subsequent 5 years, the use of atypical antipsychotics to treat dementia decreased by nearly 50%. [47] As of now, the only FDA-approved atypical antipsychotic for alzheimer-related dementia is brexpiprazole.
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The FDA, in its drug shortage list, listed the 0.25 mg, 0.5 mg and 1 mg doses of the drug with limited availability and that the duration of shortage was "to be decided", while the larger doses of ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Prior to the Prescription Drug User Fee Act (PDUFA), median approval times of New Drug Applications ranged between 21 and 29 months. [2] The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. [3]
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Fee Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – standard review and priority review.