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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 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.
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
An antimicrobial is an agent that kills microorganisms (microbicide) or stops their growth (bacteriostatic agent). [1] Antimicrobial medicines can be grouped according to the microorganisms they act primarily against. For example, antibiotics are used against bacteria, and antifungals are used against fungi. They can also be classified ...
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 also said that using unapproved animal drugs in humans could delay effective treatment and allow infections to become severe and resistant to antibiotics and anti-fungal drugs.
The main uses of mepacrine are as an antiprotozoal, antirheumatic, and an intrapleural sclerosing agent. [2] Mepacrine is used off label as a primary antimicrobial agent for patients with metronidazole-resistant giardiasis and patients who should not receive or cannot tolerate metronidazole. Giardiasis with a high level of drug resistance may ...