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2. Approved Drug Products with Therapeutic Equivalence ...

   en.wikipedia.org/wiki/Approved_Drug_Products...

   Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests ...

3. List of withdrawn drugs - Wikipedia

   en.wikipedia.org/wiki/List_of_withdrawn_drugs

   Alpidem (Ananxyl) 1995. Worldwide. Not approved in the US, withdrawn in France in 1994 [4] and the rest of the market in 1995 because of rare but serious hepatotoxicity. [3] [5] Alosetron (Lotronex) 2000. US. Serious gastrointestinal adverse events; ischemic colitis; severe constipation. [2]

4. List of drugs granted breakthrough therapy designation

   en.wikipedia.org/wiki/List_of_drugs_granted...

   Amgen. non-small cell lung cancer with KRAS G12C mutation. Avapritinib. Blueprint Medicines Corp. granted for two indications: mast cell leukemia and advanced systemic mastocytosis. Belumosudil. Kadmon Pharmaceuticals. chronic graft-versus-host disease. Pembrolizumab.

5. How a new FDA-approved drug can — and can’t — help people ...

   www.aol.com/fda-approved-drug-t-help-121600044.html

   In early 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new Alzheimer’s drug called Leqembi. (Biogen, a biotechnology company, and Eisai, a pharmaceutical ...

6. Approved drug - Wikipedia

   en.wikipedia.org/wiki/Approved_drug

   Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. Drug companies seeking to sell a drug in the United States must first test it.

7. Center for Drug Evaluation and Research - Wikipedia

   en.wikipedia.org/wiki/Center_for_Drug_Evaluation...

   The Center for Drug Evaluation and Research ( CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research.

8. US FDA approves Novartis' kidney disease drug - AOL

   www.aol.com/news/us-fda-approves-novartis-kidney...

   August 7, 2024 at 2:23 PM. By Sriparna Roy. (Reuters) -The U.S. Food and Drug Administration has approved the use of Novartis' drug to reduce excess protein in the urine of patients with a type of ...

9. FDA Adverse Event Reporting System - Wikipedia

   en.wikipedia.org/wiki/FDA_Adverse_Event...

   The FDA Adverse Event Reporting System ( FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration 's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might ...