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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]
Drug Manufacturer Indication Avapritinib: Blueprint Medicines Corp: metastatic gastrointestinal stromal tumor: Teprotumumab-trbw: Horizon Therapeutics: thyroid eye disease: Nintedanib: Boehringer Ingelheim: chronic fibrosing interstitial lung diseases: Ipilimumab: Bristol-Myers Squibb: hepatocellular carcinoma: Nivolumab: Bristol-Myers Squibb ...
The drug or other substance has a currently [1] 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.
The Food and Drug Administration (FDA) approved a weight-loss drug to help sleep apnea, becoming the first drug to treat the disorder affecting millions of Americans. On Friday, the federal agency ...
The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. Abuse of the drug or other substances may lead to severe psychological or physical dependence. The complete list of Schedule II substances is as follows.
In May, the Food and Drug Administration approved as many as 13 new drugs, higher than the eight approved in the same month last year.
The U.S. Food and Drug Administration on Thursday approved Roche's drug for a chronic blood disorder, the Swiss drugmaker said. The drug crovalimab, branded as PiaSky, is a monthly under-the-skin ...
The drug or other substance has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use of the drug or other substance under medical supervision. The complete list of Schedule I substances is as follows. [1] The Administrative Controlled Substances Code Number for each substance is included.