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FDA-labelled indication? TGA-labelled indication? MHRA-labelled indication? Literature support Acute infective exacerbation of COPD: Yes: No: No: Clinical trials are lacking. Prophylaxis in HIV-infected individuals: No: No: No: Effective in one Ugandan study on morbidity, mortality, CD4-cell count, and viral load in HIV infection. [31] Otitis media
This list is not limited to drugs that were ever approved by the FDA. Some of them (lumiracoxib, rimonabant, tolrestat, ximelagatran and ximelidine, for example) were approved to be marketed in Europe but had not yet been approved for marketing in the US, when side effects became clear and their developers pulled them from the market.
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 ...
The Food and Drug Administration began to review the safety of triclocarban and triclosan in the 1970s, but due to the difficulties of finding antimicrobial alternatives, no final policy, or "drug monograph," was established. [20] Legal action by the Natural Resources Defense Council in 2010 forced the FDA to review triclocarban and triclosan. [20]
The FDA stated "There is no data demonstrating that over-the-counter antibacterial soaps are better at preventing illness than washing with plain soap and water". [6] The agency also asserted that despite requests for such information, the FDA did not receive sufficient data from manufacturers on the long-term health effects of these chemicals.
It's chic in some circles to toss around the word "regulations" as if it's profanity. Deregulation, the logic goes, is always a good solution and all regulations are at best a necessary but ...
The FDA announced a proposal to remove oral phenylephrine, found in many popular OTC decongestants, from shelves. The reason for the ban is that the ingredient just isn’t effective, the FDA says.
Triclosan was used as a hospital scrub in the 1970s. Prior to its change in regulatory status in the EU and US, it had expanded commercially and was a common ingredient in soaps (0.10–1.00%), shampoos, deodorants, toothpastes, mouthwashes, cleaning supplies, and pesticides. [3]