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TIBSOVO (nda211192)- (250MG)

IVOSIDENIB SERVIER
250MG
Yes No
2039-Jun-07 2023-Jul-20
None None
None No
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia (AML)  In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Relapsed or refractory AML  For the treatment of adult patients with relapsed or refractory AML. Locally Advanced or Metastatic Cholangiocarcinoma  For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated.
0 0 0
Total Other Developers 2
Drugs with Suitability No
250MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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