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Alembic Pharma gets tentative USFDA nod for schizophrenia treatment drug

Press Trust of India  |  New Delhi 

Drug firm has received tentative approval from the US health regulator for tablets, used to treat 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," said in a filing.

The tentatively approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed (RLD), tablets of Vanda Pharmaceuticals, Inc.

Quoting IQVIA sales data, the company said, 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

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Wed, July 11 2018. 12:25 IST