RT Book, Section
A1 Murri, Nelda
A2 Brunton, Laurence L.
A2 Chabner, Bruce A.
A2 Knollmann, Björn C.
SR Print(0)
ID 1127872342
T1 The Goodman & Gilman Year in Review: 2013 New and Noteworthy FDA Approvals
T2 Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 12e
YR 2015
FD 2015
PB McGraw-Hill Education
PP New York, NY
SN 9780071624428
LK accessanesthesiology.mhmedical.com/content.aspx?aid=1127872342
RD 2023/09/29
AB The  FDA  approved  40  new  drugs  and  biologics  of  note  in  2013.  Twenty-two  are  pharmacologically  similar  to  others  already  marketed  and  10  are  newly  licensed  biologics  (see  part  2  of  this  series).  The  remainder  represent  eight  first-in-class  agents  indicated  for  the  management  of  cancer,  diabetes,  hepatitis  C  infection,  hypercholesterolemia,  multiple  sclerosis,  and  pulmonary  hypertension  (Table  69-1).  Three  drugs,  ibrutinib  (IMBRUVICA)  for  lymphoma  (Table  69-1),  obinutuzumab  (GAZYVA)  for  chronic  lymphocytic  leukemia  (see  part  2  of  this  series),  and  sofosbuvir  (SOVALDI)  for  hepatitis  C  infection  (Table  69-1),  were  the  first  drugs  to  be  approved  under  FDA's  "breakthrough  therapy"  designation.1  Established  in  2012,  FDA  reserves  breakthrough  designations  for  drugs  exhibiting  superior  efficacy  against  serious  diseases.