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Alembic Pharmaceuticals has received tentative approval for Iloperidone tablets, from the US health regulator.
The approved tablet is used for treating schizophrenia in adults and this tentatively approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD), Fanapt tablets of Vanda Pharmaceuticals, Inc.
Further, the company in a BSE filing stated, “The approval has been granted in the strengths of 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg.”
