A sampling of drugs, drug classes or therapeutic areas that could benefit from stakeholder collaboration  Long-acting beta agonists (LABA)Some patients who take long-acting beta agonists (LABAs) for asthma experience exacerbations of asthma symptoms, which can result in hospitalizations and death. On June 2, 2010, FDA announced revisions to the prescribing information for LABA labels…
Information Regarding Insulin Storage and Switching Between Products in an Emergency
Back to Natural Disaster Response Insulin Storage and Potency Insulin from various manufacturers is often made available to patients in an emergency and may be different from a patient’s usual insulin. After a disaster, patients in the affected area may not have access to refrigeration. According to the product labels from all three U.S. insulin…
Information Regarding Insulin Storage and Switching Between Products in an Emergency
Back to Natural Disaster Response Insulin Storage and Potency Insulin from various manufacturers is often made available to patients in an emergency and may be different from a patient’s usual insulin. After a disaster, patients in the affected area may not have access to refrigeration. According to the product labels from all three U.S. insulin…
FDA Drug Safety Communication: New warnings for using gadolinium-based contrast agents in patients with kidney dysfunction
 Safety AnnouncementAdditional Information for Patients Additional Information for Healthcare Professionals Data Summary Approved Gadolinium Based Contrast Agents  Safety Announcement [09-09-2010] The U.S. Food and Drug Administration (FDA) is requiring changes in the drug label for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition…
Safe Drug Use After a Natural Disaster
Back to Natural Disaster Response The Center for Drug Evaluation and Research (CDER) at the FDA offers the following information on the use of drugs that have been potentially affected by fire, flooding or unsafe water and the use of temperature-sensitive drug products when refrigeration is temporarily unavailable. Drugs Exposed to Excessive Heat, such as…
FDA Drug Safety Communication: New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients
Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [09-15-2010] The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals of new pediatric dosing recommendations for Valcyte (valganciclovir hydrochloride) oral tablets and oral solution. This change is being made to prevent potential valganciclovir overdosing in children with low body weight,…
National Drug Code Directory
The NDC serves as universal product identifier for human drugs. Update frequency: Semimonthly Search National Drug Code Directory Download Data Files (Data Files Updated through 9/15/2010) What are the NDC Number and the National Drug Code Directory? The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA)…
Electronic Orange Book (EOB) Query data files
The following describes the Approved Drug Products EOB Query web files. The files are ASCII text tilde (~) delimited. They are zipped into a file: EOBZIP.ZIP (Last updated 9/20/2010) Allow for approximately 5 megabytes for the unzip process. 1.     PRODUCTS.TXT Tilde (~) delimited Orange Book approved products: Ingredient The active ingredient(s) for the product….
FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData SummaryReferences  Safety Announcement [09-17-2010] The U.S. Food and Drug Administration (FDA) is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone), is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this…