Alembic Pharmaceuticals Ltd has received final approval from the US FDA for its generic version of Paliperidone extended-release tablets, used to treat schizophrenia.
The approved strengths are 1.5 mg, 3 mg, 6 mg, and 9 mg, and the product is therapeutically equivalent to Janssen's Invega.
Paliperidone is also indicated for schizoaffective disorder. According to IQVIA data, the market size for these tablets is estimated at $48 million for the 12 months ending June 2024.
Alembic now has a total of 215 ANDA approvals from the USFDA, including 187 final and 28 tentative approvals.
(With Inputs From PTI.)d
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