FDA Drugs on Accelerated Approval List, 5 Years or Longer

NDA 206488

EXONDYS 51

ETEPLIRSEN

SAREPTA THERAPEUTICS

9/19/2016

FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

Not Yet Converted

NDA 207999

OCALIVA

OBETICHOLIC ACID

INTERCEPT PHARMACEUTICALS

5/27/2016

FOR THE TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITHURSODEOXYCHOLIC ACID (UDCA) IN ADULTS WITH AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN ADULTS UNABLE TO TOLERATE UDCA

Not Yet Converted

BLA 125554 Supplement 19

OPDIVO

NIVOLUMAB

BRISTOL MYERS SQUIBB

5/17/2016

FOR THE TREATMENT OF CLASSICAL HODGKIN LYMPHOMA THAT HAS RELAPSED OR PROGRESSED AFTER AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) AND POST-TRANSPLANTATION BRENTUXIMAB VEDOTIN

Not Yet Converted

NDA 204630

PROVAYBLUE

METHYLENE BLUE

PROVEPHARM SAS

4/8/2016

FOR THE TREATMENT OF PEDIATRIC AND ADULT PATIENTS WITH ACQUIRED METHEMOGLOBINEMIA

Not Yet Converted

NDA 205353

FARYDAK

PANOBINOSTAT

NOVARTIS PHARMACEUTICALS

2/23/2015

IN COMBINATION WITH BORTEZOMIB (BTZ) AND DEXAMETHASONE(DEX) FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA (MM) WHO HAVE RECEIVED AT LEAST 2 PRIOR REGIMENS, INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT

Not Yet Converted

NDA 205858

ZYDELIG

IDELALISIB

GILEAD SCIENCES

7/23/2014

FOR THE TREATMENT OF RELAPSED FOLLICULAR B-CELL NON-HODGKIN LYMPHOMA (FL) IN PATIENTS WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES AND RELAPSED SMALL LYMPHOCYTIC LYMPHOMA (SLL) IN PATIENTS WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES

Not Yet Converted