Two Food and Drug Administration advisory committees on Wednesday unanimously voted in favor of mandating weight-based dosing for children between the ages of 2 and 12 years who are being administered acetaminophen.
A Food and Drug Administration panel will discuss findings in a clinical trial that has raised concerns about the safety and efficacy of Abbott's cholesterol-lowering drug when it’s combined with similar drugs, according to an FDA announcement.
The Food and Drug Administration on Wednesday released the Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products guidance, which outlines how easy-to-use dosage delivery devices and devices that minimize the risk of unintentional overdose can be provided for such over-the-counter medicines as liquid pain relievers, cold medicine, cough syrups and digestion aids.
The Food and Drug Administration on Wednesday issued four warning letters to companies that manufacture and market over-the-counter drug products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria, or MRSA.
The Food and Drug Administration has received reports of a rare and usually deadly cancer in patients using a class of biotech drugs to treat autoimmune and inflammatory diseases, the agency said Thursday.
The Food and Drug Administration on Thursday posted a notification to healthcare professionals and patients that the agency continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products, which are available as a spray, gel and liquids sold over the counter.
Usually, when the Food and Drug Administration approves a commercial version of a drug, it prohibits compounding pharmacies from producing it, but it’s making an exception in the case of a drug used to prevent premature births.
The Food and Drug Administration on Monday warned consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D.
Due to the public concern related to the nuclear incident in Japan, there has been an increased demand for such drugs as potassium iodide (KI), used to prevent and treat the harmful effects of radiation, according to a Food and Drug Administration Web page updated Thursday.
The Food and Drug Administration on Wednesday announced that the only over-the-counter asthma inhaler sold in the United States no longer will be available as of Dec. 31 as part of an international agreement to stop the use of substances that damage the environment.
The Food and Drug Administration on Tuesday outlined a new campaign attacking fraudulent weight-loss products marketed as dietary supplements, especially those companies that proffer a “magic pill” that almost immediately achieves weight loss.