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…