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- W4236074377 abstract "A total of 50 new molecular entities, vaccines, and blood-derived products won FDA marketing approval last year, compared with 37 in 2011. Highlights of several of the approved medications appear below. A full list of new products and their indications appears on page 178. First-in-class drugs. FDA’s Center for Drug Evaluation and Research (CDER) identified more than a dozen new drugs as the first in their class to be approved by the agency. First-in-class drugs are defined by CDER as those that “for example, use a new and unique mechanism of action for treating a medical condition.” First-in-class drugs approved during 2012 cover a wide range of illnesses. Eisai Co.’s perampanel, or Fycompa, a noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid glutamate receptor antagonist, was approved in October for the treatment of some forms of epilepsy. The cystic fibrosis transmembrane conductance regulator potentiator ivacaftor, or Kalydeco, by Vertex Pharmaceuticals Inc., was approved in January. Ivacaftor is the first FDA-approved drug that targets an underlying cause of cystic fibrosis rather than treating its symptoms. The drug is indicated for use in patients whose cystic fibrosis transmembrane conductance regulator gene expresses the G551D mutation." @default.
- W4236074377 created "2022-05-12" @default.
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- W4236074377 date "2013-02-01" @default.
- W4236074377 modified "2023-09-23" @default.
- W4236074377 title "New drug and biological product approvals, 2012" @default.
- W4236074377 doi "https://doi.org/10.2146/news130009" @default.
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