MB: FDA has told two drug companies to stop marketing sublingual nitroglycerin tablets that have not been approved as safe and effective by the FDA. Glenmark Generics and Konec Inc., have been selling unapproved nitroglycerin in 0.3, 0.4, and 0.6 mg dosages. FDA has seen significant problems with the quality and efficacy of nitroglycerin tablets that are not approved.
AR: Although Glenmark Generics and Konec must stop shipping these drugs by September 2010, there shouldn't be a supply problem. Pfizer's Nitrostat tablets, which are FDA-approved, come in the same dosages.
MB: Hospitals and pharmacies that now buy the unapproved nitroglycerin tablets will need to switch to approved ones. Patients who currently take the unapproved products should continue to take their medications and talk to their healthcare professional about their treatment options. You can find more information on our website.

标题
Unapproved Sublingual Nitro Halted (FDA)

视频介绍
FDA Patient Safety News - June, 2010 - Show #99
FDA has told two drug companies to stop marketing sublingual nitroglycerin tablets that have not been approved as safe and effective by the FDA.

Speaker #1: Mark Barnett (MB), Assistant Director, Education & Communication, U.S. Food and Drug Administration

Speaker #2: Anita Rayner (AR), Associate Director, Policy & Communications, U.S. Food and Drug Administration