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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.
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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.

 

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