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5 new drugs approved by the U.S. FDA in June
2015-07-07         

Trade name

General name

Action

ResearchCompany

 

ApprovedDay

Kengreal

Cangrelor

Antiplatelet agents

Medicines Co

06/22/2015

Metaxalone

Metaxalone

Adjuvant therapy for relieving pain

Corepharma

06/01/2015

Albenza

Albendazole

Anthelminthic

Anedra pharms

06/11/2015

Codeine phosphate / chlorphenamine maleate compound sustained-release reagent

Codeine phosphate / chlorphenamine maleate compound sustained-release reagent

Cough caused by upper respiratory tract infection

Spriaso LLC

06/22/2015

Linezolid

Linezolid

Treatment of gram positive infections caused by Gram positive bacteria

Hospira INC

06/18/2015

         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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