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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:
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
"Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues.
The therapy, called Casgevy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is the first medicine to be approved in the United States that uses the gene-editing tool CRISPR, which won its ...
Largest selling pharmaceutical products of 2015. Drugs with sales above $5 billion in 2015 ... Astellas Pharma US: Overactive bladder: Feb-2000: 2018-Nov 68: Dexilant:
Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid-based drugs, distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from a biological source.
In October 2014, the company acquired the US sales and marketing rights to the osteoarthritis drug Pennsaid from Nuvo Research for $45 million. [8] In March 2015, the company acquired Hyperion Therapeutics for $1.1 billion, increasing Horizon's orphan disease drug portfolio. [9] In December, the company acquired Crealta Holdings for $510 ...
Acorda Therapeutics, Inc. is an American biotechnology company based in Pearl River, New York.The company develops therapies that improve neurological function in people with Parkinson's disease, multiple sclerosis and other neurological disorders.
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