Review of new drugs approved by FDA in May 2015

Source: Xinkangjie / Jinyi, June 5, 2015, in May 2015, FDA of the United States approved 7 new drugs, 1 class 1 new molecular entity drug, 3 class 4 new compositions, and 3 class 5 new specifications or new manufacturer drugs The new drugs approved by FDA are classified according to their chemical types and therapeutic potential According to the chemical types, new drugs are mainly divided into: 1 new molecular solid compounds (NME), which are the most innovative It refers to the active ingredient that has never been approved or sold as a drug in the United States, which can be a single component or a part of stereoisomeric mixture; 2 new derivatives It is derived from the listed active ingredients (the so-called "patent" drugs), that is, the esters, salts or other non covalent derivatives of the active ingredients listed in the United States, or the parent compounds of the unmodified groups are not approved for listing in the United States; 3 new dosage forms The indications of the new dosage forms or new prescriptions containing the listed active ingredients may be the same as or different from those of the listed products; 4 types of new compositions There are two or more varieties of active ingredients on the market, but there is no such combination in the products on the market; 5 new specifications or producers of drugs; 6 new indications Replicas with new uses approved or listed by the same company or other companies in the United States; 7 types of drugs listed but not approved by NDA The indications are the same as the products on the market, but also different; 8 kinds of drugs are changed into over-the-counter drugs; 10 kinds of new drug applications with different indications Table 1 new drugs approved by FDA in May 2015 note: 1) classification of new chemical drugs: Class 1 new molecular entity compounds; class 4 new compositions; class 5 new specifications or new manufacturers; 2) classification of approval: P priority review; s routine review of new molecular entity drugs viberzi (elugadoline) On May 27, 2015, the US FDA approved the new molecular entity drug viberzi (elugadoline) of diarrhea type irritable bowel syndrome of furiex pharmaceutical company to be listed on the market Viberzi is a mu opioid receptor agonist, which acts on mu opioid receptor to play a role in the treatment of diarrhea type irritable bowel syndrome There are two specifications of viberzi, 100mg and 75mg, which are taken twice each time and taken at the time of eating.