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LIVDELZI (NDA217899)- (EQ 10MG BASE)

SELADELPAR LYSINE GILEAD SCIENCES INC
EQ 10MG BASE
No No
2035-Mar-19 2029-Aug-14
None None
None No
LIVDELZI is a peroxisome proliferator-activated receptor (PPAR)-delta agonist indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
0 0 0
Total Other Developers None
Drugs with Suitability No
EQ 10MG BASE ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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