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The FDA requires OTC products to be labeled with an approved "Drug Facts" label to educate consumers about their medications. The labels comply to a standard format and are intended to be easy for typical consumers to understand.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
The agency approved phenylephrine for over-the-counter use in the 1970s, but it became even more common after 2005, when legislation restricted access to OTC drugs that use a similar decongestant ...
On Thursday, the FDA proposed removing oral phenylephrine from the list of approved active ingredients for over-the-counter (OTC) nasal decongestants, citing concerns over its effectiveness. After ...
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 US Food and Drug Administration has approved the oral contraceptive Opill for over-the-counter use, making it the first nonprescription birth control pill in the United States.
Orlistat was initially approved by the U.S. Food and Drug Administration in April 1999 as a prescription-only medication. [40] On 23 January 2006, an FDA advisory panel voted 11 to 3 to recommend the approval of an OTC formulation of orlistat, to be sold under the brand name Alli by GlaxoSmithKline . [ 41 ]
On Thursday, the Food and Drug Administration (FDA) approved pharmaceutical company Perrigo’s Opill, the first over-the-counter birth control pill, which will let individuals obtain the ...