The FDA has approved a new treatment for Type 2 diabetes, the agency said. The FDA announced the approval of Tradjenta (linagliptin) made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.
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.
The National Association of Chain Drug Stores delivered on Tuesday testimony on the safe usage of pediatric acetaminophen products before a joint meeting of the Food and Drug Administration Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee.
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.
Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.
The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.
A recent Food and Drug Administration inspection prompted the recall of dietary supplements distributed by Multi-Mex Distributor, the company announced Monday. According to an FDA post, the supplements in question bore a close resemblance to antibiotics available in Mexico and may have been confusing to Hispanic consumers.
The Food and Drug Administration will expedite its review of an investigational drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the gastrointestinal tract, the company said Tuesday.