FDA Safety Labeling Changes: Celexa, Lexapro, Premarin, and OthersYael WaknineMedscape
Lovastatin (Mevacor) Drug Interactions Linked to Increased Risk of Myopathy, Rhabdomyolysis On June 13, the FDA approved safety labeling revisions for lovastatin (Mevacor tablets, made by Merck & Co., Inc.) to advise of certain drug interactions that increase the risk of myopathy/rhabdomyolysis ass...
Sept. 15, 2004 — The U.S. Food and Drug Administration (FDA) approved in June revisions to safety labeling to advise healthcare professionals of the following changes: adalimumab has been associated with a risk for malignancy, hypersensitivity reactions, and hematologic adverse events; hypersensitiv...
Drug Establishments Current Registration Site Search药品经营机构现行注册网站查询 Drug Safety-related Labeling Changes (SrLC) 药品安全相关标签变更(SrLC) Drug Shortages药品短缺 Drugs@FDA Search药品@FDA搜索 已上市药品的信息可通过药品名称、原料药名称和申请号快速查询,也可通过药品...
The article presents the summaries of the changes being made to the safety labeling of drugs and therapeutic biologics. These changes were made as part of the Food and Drug Administration's (FDA) MedWatch Program. The changes include boxed warnings which are posted on its website. Boxed warnin...
The MedWatch Program: Safety-Related Drug Labeling Changes Approved by FDAEvaluation the etiopathogenesis of this set autoimmune muscle diseases.doi:10.3109/15563659809028037White, Gale G.Love, LoriTaylor & FrancisClinical Toxicology
2. Container-Closure Changes 容器密闭器变化 Question 1:问 1 If the reference listed drug (RLD) is asterile injectable drug product packaged in an ampule, can the generic productbe packaged in a vial?如果 RLD(参比制剂) 为安瓿瓶装无菌注射剂，仿制药可以装在西林瓶中吗？ Answer 1:答 1 A ...
FDA initiated class safety labeling changes (2024 Safety and Availability Communications). FDA concluded that changes to the Boxed Warning are warranted to highlight the serious risk of T cell malignancies. In addition, FDA has required related updates to other sections of the label (Warnings and ...
[12/20/2018 - Drug Safety Communication - FDA] Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side EffectsJul 10, 2018 | Audience: Patient, Health Professional, Pharmacy ISSUE: FDA is strengthening the current warnings in the prescribing ...
The FDA today issued a safety communication for patients and their health care providers that stresses the importance of shared decision-making regarding use of laparoscopic power morcellators during gynecologic surgeries.The safety communication also in