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REZDIFFRA (NDA217785)- (60MG,80MG,100MG)

RESMETIROM MADRIGAL
60MG,80MG,100MG
No No
2033-Sep-17 2029-Mar-14
None None
None No
REZDIFFRA is a thyroid hormone receptor-beta (THR-beta) agonist indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of NASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
0 0 0
Total Other Developers 2
Drugs with Suitability No
60MG ** ** - - -
80MG ** ** - - -
100MG ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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