Comprehensive information |
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Comprehensive information |
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5 new drugs approved by the U.S. FDA in June |
2015-07-07 |
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Trade name
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General name
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Action
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ResearchCompany
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ApprovedDay
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Kengreal
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Cangrelor
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Antiplatelet agents
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Medicines Co
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06/22/2015
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Metaxalone
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Metaxalone
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Adjuvant therapy for relieving pain
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Corepharma
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06/01/2015
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Albenza
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Albendazole
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Anthelminthic
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Anedra pharms
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06/11/2015
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Codeine phosphate / chlorphenamine maleate compound sustained-release reagent
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Codeine phosphate / chlorphenamine maleate compound sustained-release reagent
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Cough caused by upper respiratory tract infection
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Spriaso LLC
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06/22/2015
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Linezolid
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Linezolid
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Treatment of gram positive infections caused by Gram positive bacteria
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Hospira INC
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06/18/2015
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FDA approval of the new drug is mainly based on the type of drug chemistry and therapeutic potential to classify. New drugs by chemical types are mainly divided into: 1 new molecular entities (NME), the most innovative. The active ingredient in the United States, which has never been used as a drug in the United States, can be a single component or a part of a solid, heterogeneous mixture; 2 new derivatives. From has been listed on the active components (i.e., the so-called "patent") medicine chemical derivatization, is already listed in the United States active ingredients of ester, salt, or other non covalent bond derivative of, or to a radical modification of the parent compounds were not approved in the United States listed the; three kinds of new dosage forms. A new formulation or a new formulation containing the active ingredients of the active ingredient, which can be adapted to the same as the market, may also be different; 4 new compositions. Two or more than two kinds of active ingredients listed, there is no such combination of listed products; 5 new specifications or new manufacturers of drugs; 6 new indications. A copy of the approved or marketed by the same company or other company in the United States; the 7 category has been listed but not approved by NDA. Indications have been the same as the listed products, but also different; the 8 Category of non prescription drugs; 10 different types of new drug application.
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