Search results
Results From The WOW.Com Content Network
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:
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
In the United States, the FDA approves drugs. 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. [2] Drug companies seeking to sell a drug in the United States ...
Description - includes the proprietary name (if any), nonproprietary name, dosage form(s), qualitative and/or quantitative ingredient information, the pharmacologic or therapeutic class of the drug, chemical name and structural formula of the drug, and if appropriate, other important chemical or physical information, such as physical constants ...
It is referred to as the Purple Book. It was published in 1991 (ISBN 0-63202-8475) by Blackwell Science. The author of this book is W.V. Metanomski. The expansion of this book named Compendium of Polymer Terminology and Nomenclature: IUPAC Recommendations, 2008 was published by the Royal Society of Chemistry in 2009 (ISBN 978 0 85404 491 7).
With standard FDA approval, Medicare has said it will reimburse patients for the treatment as long as their doctors collect data and submit it to a free health agency database, known as a registry.
Nivolumab, sold under the brand name Opdivo, is an anti-cancer medication used to treat a number of types of cancer. [2] This includes melanoma, lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colon cancer, esophageal squamous cell carcinoma, liver cancer, gastric cancer, and esophageal or gastroesophageal ...
The gene therapy will compete with Australia-based CSL Behring’s Hemgenix, a similar treatment that won FDA approval for hemophilia B in 2022. That drug has a similar list price of $3.5 million ...