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Alembic Pharmaceuticals has received tentative approval from the US health regulator for Iloperidone tablets, used to treat schizophrenia in adults.
“The approval has been granted in the strengths of 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg,” Alembic Pharmaceuticals said in a BSE filing today.
The tentatively approved abbreviated new drug application is therapeutically equivalent to the reference listed drug product, Fanapt tablets of Vanda Pharmaceuticals, Inc.
Quoting IQVIA sales data, Iloperidone tablets have an estimated market size of $128 million for the 12 months ended December 2017. The company said it has 74 ANDA approvals from the USFDA.
Alembic Pharma stock was trading at Rs 526.75, up 1.84 per cent, on the BSE.
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