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FASLODEX (nda021344)- (250MG/5ML (50MG/ML))

FULVESTRANT ASTRAZENECA
250MG/5ML (50MG/ML)
Yes No
2022-Apr-09 Expired
None None
None No
FASLODEX is an estrogen receptor antagonist indicated for the treatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. • HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. • HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
14 0 14
Total Other Developers 11
Drugs with Suitability No
250MG/5ML (50MG/ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 13
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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