Drug firm 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.
The tentatively approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD), Fanapt tablets of Vanda Pharmaceuticals, Inc.
Quoting IQVIA sales data, the company said, Iloperidone tablets have an estimated market size of USD 128 million for 12 months, ending December 2017.
The company said it now has a total of 74 ANDA approvals from the USFDA.
The company's stock was trading at Rs 526.75, up 1.84 per cent, on the BSE.
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