FDA gives tentative OK for Lupin's generic Rexulti
Brexpiprazole tablets had a market value of roughly $1.3 billion, according to IQVIA data from July 2021.
The Food and Drug Administration has given Lupin tentative approval for brexpiprazole tablets, in dosage strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.
The medication is a generic of Otsuka’s Rexulti.
Brexpiprazole tablets are indicated as an adjunctive therapy to anti-depressants for the treatment of major depressive disorder, and schizophrenia.
[Read more: Lupin launches 3 generics]
Lupin's generic Rexulti tablets will be manufactured at the company's Plthampur facility.
Brexpiprazole tablets had a market value of roughly $1.3 billion, according to IQVIA data from July 2021.