How to accurately check the listing status of Quizartinib

As an oral drug targeting FLT3 mutations, the marketing progress of Quizartinib has attracted close attention from drug regulatory agencies in many countries around the world. The current marketing status of the drug can be inquired through a variety of formal channels to ensure that the information is authoritative and timely.

First of all, the most direct way is to visit the official website of the U.S. Food and Drug Administration (FDA). Enter "Quizartinib" or its trade name "VANFLYTA" in the FDA's "Drugs@FDA" database to check the drug's approval status in the United States. According to an announcement issued by the FDA in July 2023, quizartinib has been officially approved as a combination treatment regimen for adult patients with FLT3-ITD mutation-positive acute myeloid leukemia.

Secondly, the European Medicines Agency (EMA) has also approved the use of quizartinib in the EU market in November 2023. On the EMA official website, you can also find approval details by searching the drug name through its "EPAR" (European Public Assessment Reports) section, including core information such as indications, clinical assessment reports, and risk management plans.

The third country that has approved the marketing of quizartinib is Japan. The drug passed the review of Japan's PMDA (Pharmaceuticals and Medical Devices Agency) in October 2019, and was launched as the first country in the world to be approved. This information can be found on the PMDA official website and is especially useful for patients or medical staff who need to understand regulatory trends in Asia.

For users who want to know the domestic situation in China, they can check the "Center for Drug Evaluation (CDE)" database on the official website of the National Medical Products Administration (NMPA). As of now, Quizartinib has not been approved for marketing in mainland China. The original drug was developed by Japan's Daiichi Sankyo Company under the trade name VANFLYTA. There is no public information in China showing that the drug has entered the review stage, so the market price, medical insurance coverage, etc. are still uncertain.

Reference materials:https://go.drugbank.com/drugs/DB12874