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PDUFA date. In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. [1] It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and ...
Alpidem (Ananxyl) 1995. Worldwide. Not approved in the US, withdrawn in France in 1994 [ 4] and the rest of the market in 1995 because of rare but serious hepatotoxicity. [ 3][ 5] Alosetron (Lotronex) 2000. US. Serious gastrointestinal adverse events; ischemic colitis; severe constipation. [ 2] Reintroduced 2002 with restricted indication and ...
6 2018. 7 2017. 8 2016. 9 2015. 10 2014. 11 2013. ... (BTD) by the US Food and Drug Administration (FDA). Drugs may be listed more than once since breakthrough ...
New Drug Application. The Food and Drug Administration 's (FDA) New Drug Application ( NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. [ 1][ 2] Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug ...
August 7, 2024 at 2:23 PM. By Sriparna Roy. (Reuters) -The U.S. Food and Drug Administration has approved the use of Novartis' drug to reduce excess protein in the urine of patients with a type of ...
Bad news: The 27 new drugs approved this year is a far cry from 2012's banner year for approvals, in which the Food and Drug Administration signed off on 39 drugs. Good news: While the quantity ...
The Food and Drug Administration has given regulatory clearance for the use of Pfizer's Prevnar 13 vaccine in children between the ages of 6 and 17. Prevnar 13, a pneumococcal conjugate vaccine ...
In November 2018, the US FDA granted accelerated approval to pembrolizumab for those with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. [73] In February 2019, the US FDA approved pembrolizumab for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. [74]