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IMCIVREE (nda213793)- (EQ 10MG BASE/ML (EQ 10MG BASE/ML))

SETMELANOTIDE ACETATE RHYTHM
EQ 10MG BASE/ML (EQ 10MG BASE/ML)
No No
2034-Jul-04 2025-Nov-25
None None
None No
IMCIVREE is a melanocortin 4 (MC4) receptor agonist indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to: • Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS). • Bardet-Biedl syndrome (BBS).
0 0 0
Total Other Developers None
Drugs with Suitability No
EQ 10MG BASE/ML (EQ 10MG BASE/ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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