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MODEYSO (NDA219876)- (EQ 125MG BASE)

DORDAVIPRONE HYDROCHLORIDE CHIMERIX
EQ 125MG BASE
No No
2037-Jan-30 2030-Aug-06
None None
None No
MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
0 0 0
Total Other Developers None
Drugs with Suitability No
EQ 125MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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