Search results
Results from the WOW.Com Content Network
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]
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]
Main page; Contents; Current events; Random article; About Wikipedia; Contact us
In 2003 Public Citizen filed a citizen petition asking the FDA to withdraw the marketing authorization in the United States, and in early 2004 the organization sued the FDA to attempt to force withdrawal of the drug. [43] [44] The FDA issued a response to the petition in June 2004 and filed a motion to dismiss, and Public Citizen withdrew the ...
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]
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 ...
The FDA began enforcing its new powers against drug manufacturers who could not substantiate the efficacy claims made for their drugs, and the United States Court of Appeals for the Ninth Circuit ruling in Alberty Food Products Co. v. United States (1950) found that drug manufacturers could not evade the "false therapeutic claims" provision of ...
The United States Food and Drug Administration (FDA) initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need. The faster approval relies on use of surrogate endpoints . [ 1 ]