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An Australian Approved Name (AAN) is a generic drug name set by the Therapeutic Goods Administration (TGA) for use in Australia. [1] In late 2016, the TGA changed several drug names to the corresponding international nonproprietary name (INN), or, in cases where an INN was not available (as with asparaginase), another established generic name, such as the United States Adopted Name (USAN).
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. [4] As part of the Department of Health and Aged Care, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods).
Schedule 9 (S9) drugs and poisons are substances and preparations that, by law, may only be used for research purposes. The sale, distribution, use, and manufacture of such substances without a permit is strictly prohibited by law. Permits for research uses on humans must be approved by a recognised ethics committee on human research. Examples ...
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
It was approved for medical use in the United States and in the European Union in 2015, [11] [12] [13] [7] and in Australia in 2016. [1] In 2021, it was the 189th most commonly prescribed medication in the United States, with more than 2 million prescriptions. [14] [15] It is available as a generic medication. [16]
Ivosidenib, sold under the brand name Tibsovo, is an anti-cancer medication for the treatment of acute myeloid leukemia (AML) and cholangiocarcinoma. [4] It is a small molecule inhibitor of isocitrate dehydrogenase-1 (IDH1), which is mutated in several forms of cancer. Ivosidenib is an isocitrate dehydrogenase-1 inhibitor that works by ...
Vosoritide. Vosoritide, sold under the brand name Voxzogo, is a medication used for the treatment of achondroplasia, [3][4][5] a genetic condition that causes severely short stature and disproportionate growth. [4] Achondroplasia is caused by a genetic mutation that increases the activity of a certain growth regulation gene called fibroblast ...
Belzutifan is the first drug to be awarded an "innovation passport" from the UK Medicines and Healthcare products Regulatory Agency (MHRA). [16] [11] Belzutifan was approved for medical use in the United States in August 2021. [9] [17] Belzutifan is the first hypoxia-inducible factor-2 alpha inhibitor therapy approved in the US. [17]