Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)
The product will be commercialized from Unichem's Ghaziabad plant
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