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AFINITOR DISPERZ (nda203985)- (2MG,3MG,5MG)

EVEROLIMUS NOVARTIS PHARM
2MG,3MG,5MG
Yes No
2023-Mar-27 2014-Mar-30
2017-Oct-29 None
None No
AFINITOR DISPERZ are kinase inhibitors indicated for the treatment of: • pediatric and adult patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. The effectiveness is based on demonstration of durable objective response, as evidenced by reduction in SEGA tumor volume. Improvement in disease-related symptoms and overall survival in patients with SEGA and TSC has not been demonstrated.
1 0 1
Total Other Developers 3
Drugs with Suitability No
2MG ** ** - - -
3MG ** ** - - -
5MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 1
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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