The U.S. Food and Drug Administration today issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.
Category Archives: Drug Safety Information Podcasts
FDA approves first generic version of cholesterol-lowering drug Lipitor
The U.S. Food and Drug Administration today approved the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets).
FDA: U.S. Marshals seize dietary supplements, drugs manufactured by Syntec Inc.
U.S. Marshals, at the request of the FDA, today seized all dietary supplements by a Wisconsin maker for false claims made about their safety and effectiveness in treating a number of diseases.
FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep
The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.
FDA permits marketing of a system to repair failed, problematic fix for aortic aneurysms
The U.S. Food and Drug Administration today allowed marketing of the first system that can repair a failed or problematic aortic endograft, a fabric tube used to repair a dangerously large aortic aneurysm, a bulge in the large blood vessel that carries blood away from the heart.
FDA approves Eylea for eye disorder in older people
The U.S. Food and Drug Administration today approved Eylea (aflibercept) to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.
AMD gradually destroys a person’s sharp, central vision.
FDA approves Erwinaze to treat a form of leukemia
The U.S. Food and Drug Administration today approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs used to treat ALL.
FDA Commissioner announces Avastin decision
FDA Commissioner Margaret A. Hamburg, M.D., said today she is revoking the agency’s approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.
FDA approves first supplemental test for Chagas disease
The U.S. Food and Drug Administration today approved the first test for use as an additional, more specific test on human serum or plasma specimens found to be positive for antibodies to Trypanosoma cruzi (T. cruzi). T. cruzi causes Chagas disease, a serious and potentially fatal parasitic infection.
FDA Statement on the International Tobacco Regulators’ Conference
This week, 65 representatives of health and regulatory agencies from 22 countries attended the International Tobacco Regulators’ Conference, hosted by the U.S. Food and Drug Administration and the World Health Organization Tobacco Free Initiative.