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AFINITOR (nda022334)- (2.5MG,5MG,7.5MG,10MG)

EVEROLIMUS NOVARTIS
2.5MG,5MG,7.5MG,10MG
Yes No
2028-Jul-01 2014-Mar-30
2017-Oct-29 None
None No
AFINITOR is a kinase inhibitor indicated for the treatment of: • postmenopausal women with advanced hormone receptor-positive, HER2negative breast cancer (advanced HR+ BC) in combination with exemestane after failure of treatment with letrozole or anastrozole. • adults with progressive neuroendocrine tumors of pancreatic origin (PNET) that are unresectable, locally advanced or metastatic. The safety and effectiveness of AFINITOR in the treatment of patients with carcinoid tumors have not been established. • adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. • adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. The effectiveness of AFINITOR in the treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. Further follow-up of patients is required to determine long-term outcomes.
6 0 6
Total Other Developers 10
Drugs with Suitability No
2.5MG ** ** - - -
5MG ** ** - - 6
7.5MG ** ** - - -
10MG ** ** - - 5
NDA Sales Available Total Generic Sales Available
Yes 5
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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