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This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
As of 2016, the EMA was roughly parallel to the drug part of the U.S. Food and Drug Administration (FDA), [53] but without centralisation. [54] The timetable for product approval via the EMA's centralised procedure of 210 days compares well with the average of 500 days taken by the FDA in 2008 to evaluate a product. [55]
Insulin detemir was approved for medical use in the European Union in June 2004 and in the United States in June 2005. [129] [127] [130] It is listed on the World Health Organization's List of Essential Medicines. [74] In 2022, it was the 127th most commonly prescribed medication in the United States, with over 4 million prescriptions. [35] [131]
Food and Drug Administration (FDA) approval date: European Medicines Agency (EMA) approval date: Health Canada approval date: Company: Single-tablet regimen? NRTIs / NtRTIs: NNRTI: INSTI: PI: PK enhancer: Combivir: lamivudine zidovudine: September 26, 1997 ViiV Healthcare: No Kaletra (developed countries) Aluvia (developing countries) lopinavir ...
National regulatory authorities have granted full or emergency use authorizations for 40 COVID-19 vaccines.. Ten vaccines have been approved for emergency or full use by at least one stringent regulatory authority recognized by the World Health Organization (WHO): Pfizer–BioNTech, Oxford–AstraZeneca, Sinopharm BIBP, Moderna, Janssen, CoronaVac, Covaxin, Novavax, Convidecia, and Sanofi ...
The idea is that countries with non-SRA drug authorities can use accelerated process to facilitate approval (registration or marketing authorization) of medicines, including vaccines and biologics, which have already been approved by SRAs. [1] As of 2022, the national regulatory authorities of 36 countries are considered SRAs: [2]
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children. For this purpose, new data used for PUMA approved drugs are protected for 10 years, and the applications are partially exempt from fees. [1] In September 2011, the first drug was approved under this process.
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