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The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Division of Gastrointestinal and Coagulation Drug Products has requested that AstraZeneca participate in a Cardiovascular and Renal Drugs Advisory Committee review of this application. This briefing document has been prepared to support that review.
1 Οκτ 2024 · The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products.
FDA has advised companies to recall their ranitidine if testing shows levels of NDMA above the acceptable daily intake (96 nanograms per day or 0.32 parts per million for ranitidine). The agency...
Exanta FDA Approval Status. FDA Approved: No. Brand name: Exanta. Generic name: ximelagatran. Company: AstraZeneca. Treatment for: Prevention of Thromboembolism in Atrial Fibrillation.
9 Φεβ 2005 · Vitamin K (“Koagulation”) antagonists have been the sole oral anticoagulants available for 60 years, ever since Link 1 identified the components in spoiled sweet clover responsible for bleeding in cattle. Originally developed as a rat poison, vitamin K antagonists such as warfarin are used successfully for the prevention of venous and arterial thromboembolism for a wide range of clinical ...
2 Απρ 2020 · Update: On April 1, 2020, the FDA requested manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs (Zantac, others) from the market immediately, due to the presence of a contaminant known as N-Nitrosodimethylamine (NDMA).
FDA provides a searchable list of recalled products. Drug recalls are actions taken by a firm to remove a product from the market and may be conducted on a firm's own initiative, by FDA...
