Data report: FDA new drug approval briefing in September 2015

The approval of new drugs has always been a hot issue of common concern in the pharmaceutical industry For this reason, Xiaobian of Yaozhi made a brief report on the data of FDA's approval of new drugs in September 2015, which is convenient for friends in the industry to intuitively understand the latest approval of new drugs On September 2, 2015, the FDA approved the use of varubi (rolapitant) in the treatment of chemotherapy-induced vomiting, which was marketed by tesaro Inc of Massachusetts Varubi (rolled agent) is mainly used in combination with other antiemetic drugs for severe vomiting caused by chemotherapy for adult cancer Usually, this vomiting symptom is delayed vomiting 24 to 120 hours after chemotherapy, which will cause a series of complications such as weight loss, dehydration and malnutrition The drug is mainly to inhibit CYP2D6 drug metabolism enzyme, which will increase the blood concentration of the drug when it is combined with methiprazine, leading to serious arrhythmia symptoms 2015.09.04 FDA approved xuriden (uridine triacetate) for the treatment of hereditary whey aciduria Hereditary whey aciduria is a rare metabolic disorder The disease is mainly caused by the lack of an enzyme that normally synthesizes uridine There are about 20 cases reported around the world The main symptoms of the disease are anemia, leucopenia, neutropenia, and urinary uric acid crystal blockage Xureden was developed and launched by wellstat therapeutics Corporation On September 17, 2015, FDA approved the use of vraylar in the treatment of schizophrenia and bipolar disorder Schizophrenia is a serious chronic brain dysfunction syndrome The typical symptoms are hallucinations, hallucinations, paranoia and cringe The main symptoms of bipolar disorder are depression and hyperactivity, emotional impatience, rapid speech, behavioral impulse, lack of sleep and so on The drug is produced by forest laboratories and distributed by Actavis pharma On September 22, 2015, the FDA approved the use of lonsurf (a combination of trifluorothoracic and tipirahi tablets) in the final treatment of colorectal cancer when other drugs have no effect The drug is mainly used for the treatment of patients whose cancer has worsened (metastasized), in which case the side effects are very serious The drug is produced by taihooncology On September 25, 2015, the FDA approved the use of tresiba (insulin inclusion injection) and ryzodeg70 / 30 (insulin inclusion C / insulin injection) to improve blood glucose control in diabetic patients Both are long-acting insulin analogues, which are beneficial to the control of blood glucose level The drug was launched by Novo Nordisk Data source: drug intelligence website FDA drug database note: the intellectual property rights of the above articles belong to drug intelligence website If you need to reprint, please indicate the source and the link of this article.