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Alpidem (Ananxyl) 1995. Worldwide. Not approved in the US, withdrawn in France in 1994 [ 4 ] and the rest of the market in 1995 because of rare but serious hepatotoxicity. [ 3 ][ 5 ] Alosetron (Lotronex) 2000. US. Serious gastrointestinal adverse events; ischemic colitis; severe constipation. [ 2 ] Reintroduced 2002 with restricted indication ...
The Food and Drug Administration (FDA) of the Philippines, formerly the Bureau of Food and Drugs (BFAD / ˈ b iː f æ d /; 1982–2009), is a health regulatory agency under the Department of Health created on 1963 by Republic Act No. 3720, amended on 1987 by Executive Order 175 otherwise known as the "Food, Drugs and Devices, and Cosmetics Act", and subsequently reorganized by Republic Act No ...
In 1832 produced chloral hydrate, the first synthetic sleeping drug. In 1833 French chemist Anselme Payen was the first to discover an enzyme, diastase. In 1834, François Mothes and Joseph Dublanc created a method to produce a single-piece gelatin capsule that was sealed with a drop of gelatin solution.
This is a complete list of clinically approved prescription antidepressants throughout the world, as well as clinically approved prescription drugs used to augment antidepressants or mood stabilizers, by pharmacological and/or structural classification. Chemical/generic names are listed first, with brand names in parentheses.
Under normal circumstances, drugs and vaccines are reviewed for approval by the Food and Drug Administration (FDA) under a period of six months. President Rodrigo Duterte to fast-track the government's medical response to the pandemic signed an executive order on December 2, 2020, which allowed the FDA to grant emergency-use authorization (EUA ...
PDUFA date. In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. [1] It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and ...
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 ...
Tezepelumab was approved for medical use in the United States in December 2021, [5] [11] [6] and in the European Union in September 2022. [ 7 ] [ 12 ] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication .