The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products.
Category Archives: Drug Recalls & Safety Notices
FDA approves new drug to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved roflumilast, a pill taken daily to decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).
FDA: Advanced genomic test helps trace sources of foodborne illness outbreak
FDA scientists successfully used a new genome sequencing test to retrospectively examine a 2009-10 foodborne illness outbreak to help trace the source of the infection. PCE
FDA: U.S. Marshals seize food products at Tennessee company
U.S. Marshals today seized about $200,000 worth of food products from Bedford Cheese Store Inc. in Shelbyville, Tenn., after U.S. Food and Drug Administration investigators found evidence of rodents throughout the company’s facility. SY
FDA and Georgetown University Medical Center announce partnership
The U.S. Food and Drug Administration and Georgetown University Medical Center (GUMC) today announced a new partnership to stimulate innovation in regulatory science, ethics, education, and training. The partnership enhances the capabilities of both institutions to meet their common goal of improving public health.
FDA approves Edarbi to treat high blood pressure
The U.S. Food and Drug Administration today approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.
Advanced genomic test helps trace sources of foodborne illness outbreak
FDA scientists successfully used a new genome sequencing test to retrospectively examine a 2009-10 foodborne illness outbreak to help trace the source of the infection. PCE
FDA permits marketing of first test for most common cause of gastroenteritis outbreaks
The Ridascreen Norovirus 3rd Generation EIA assay is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food.
FDA approves product to prevent bleeding in people with rare genetic defect
The U.S. Food and Drug Administration today approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.
FDA warns against certain uses of asthma drug terbutaline for preterm labor
The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.