FDA Medication Labeling Changes
FDA Mandate Medication Labeling Changes. Numerous drugs have been approved for use, but that does not necessarily mean that the medical community is aware of all medication side effects. In fact, changes are frequently made to a drug's warning label to reflect the most recent knowledge. For instance, the U.S. Food and Drug … [Read more...]
Labeling Changes And Instructions For 29 Products Updated April 2016
Product Labeling Changes And Instructions. Safety Labeling Changes posted by MedWatch April 2016 includes 29 products to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE. The “Summary Page” table provides a listing of product names and … [Read more...]
FDA Safety Labeling Changes: Viramune, Copegus, Malarone
Safety Labeling Changes For Viramune, Copegus, Malarone. The U.S. Food and Drug Administration (FDA) approved in February revisions to safety labeling to notify healthcare professionals of the following changes: use of nevirapine tablets and oral suspension may cause serious hepatotoxicity and skin reactions, and intensive … [Read more...]
FDA Important Labeling Changes for Mifepristone
New Safety Changes For Mifepristone. The Food and Drug Administration will announce today important new safety changes to the Danco Laboratories, LLC's labeling of mifepristone (trade name Mifeprex, also known as RU-486). Mifeprex was approved in 2000 for the termination of early pregnancy, defined as 49 days or less. FDA and … [Read more...]
