California Supreme Court – Name Manufacturers Responsible for Generic Drug Labeling
Under the Food, Drug, and Cosmetic Act, drug manufacturers must submit a new drug application before it is able to market a new brand name drug. Additionally, the United States Food and Drug Administration must approve of the drug before it may be marketed. In the new drug application, a sample of the drug’s label must be included. … [Read more...] about California Supreme Court – Name Manufacturers Responsible for Generic Drug Labeling
FDA Orders Two Firms to Stop Making Unapproved Nitroglycerin
FDA Stop Unapproved Nitroglycerin. Generic drug makers Konec Inc. and Glenmark Generics Inc. have apparently been marketing unapproved nitroglycerin tablets for years. While the Food & Drug Administration (FDA) recently ordered both firms to stop doing so, the drug continues to be sold in pharmacies while the Food & Drug … [Read more...] about FDA Orders Two Firms to Stop Making Unapproved Nitroglycerin
Congressional Actavis Totowa Probe Prompted by Digitek, Other Generic Drug Recalls
Actavis Totowa Recall Digitek, Other Generic Drug. Actavis Totowa, the company that has recalled a variety of drugs this year, including Digitek tablets and fentanyl patches, has attracted the attention of lawmakers on the House Energy and Commerce Committee. Chairman John Dingell (D-Mich.) and Oversight and Investigations … [Read more...] about Congressional Actavis Totowa Probe Prompted by Digitek, Other Generic Drug Recalls
Generic Drug Maker Able Had Problems With FDA
Generic Drug Are Being Recalled. Generic drug maker Able Laboratories Inc., which this week recalled all of its drugs and shut down manufacturing over quality questions, has a long history of problems with regulators, government documents show. U.S. Food and Drug Administration reports and letters to the company detail repeated … [Read more...] about Generic Drug Maker Able Had Problems With FDA
