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LENVIMA (nda206947)- (EQ 4MG BASE,EQ 10MG BASE)

LENVATINIB MESYLATE EISAI INC
EQ 4MG BASE,EQ 10MG BASE
Yes No
2036-Aug-23 2020-Feb-13
2022-Feb-13 None
None No
LENVIMA is a kinase inhibitor that is indicated: Differentiated Thyroid Cancer (DTC) • For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). Renal Cell Carcinoma (RCC) • In combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC). • In combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior antiangiogenic therapy. Hepatocellular Carcinoma (HCC) • For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Endometrial Carcinoma (EC) • In combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma (EC) that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
0 0 0
Total Other Developers 10
Drugs with Suitability No
EQ 4MG BASE ** ** - - -
EQ 10MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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