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The FDA required Takeda to conduct this safety study when the medicine was approved in 2009. The febuxostat drug labels already carry a warning and precaution about cardiovascular events because the clinical trials conducted before approval showed a higher rate of heart-related problems in patients treated with febuxostat compared to allopurinol.
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.
It received FDA approval on 22 December 2015. [3] The European Commission granted a marketing authorisation valid throughout the European Union on 18 February 2016. [ 4 ] In February 2019, lesinurad was discontinued in the United States by its manufacturer for business reasons, and was subsequently withdrawn in Europe in July 2020.
This is not a wholly unusual thing to do, as some drug labels do get revised after approval. Goldstein explained that Zoetis is "working actively" with the F.D.A. on the revision process.
The weight loss drug Zepbound, generically known as tirzepatide, is also now an approved medication to treat obstructive sleep apnea, per a Food and Drug Administration Dec. 20 press release.. The ...
The treatment, Tivdak - an antibody-drug conjugate co-developed by Genmab A/S and Seagen - received the FDA's accelerated approval for the same indication in 2021. It was added to Pfizer's ...
The drug or other substance has a currently [2] accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence. The complete list of Schedule III substances is as follows.
Drug Manufacturer Indication Crizotinib: PF Prism: ALK-positive systemic anaplastic large cell lymphoma: Trastuzumab deruxtecan: Daiichi Sankyo: HER2-positive gastric or gastroesophageal junction adenocarcinoma, previously treated with trastuzumab: Umbralisib: TG Therapeutics: marginal zone lymphoma, previously treated with an anti-CD20-based ...