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22 October, 2018 20:05 IST
Alembic Pharma receives USFDA tentative approval for lloperidone Tablets
Source: IRIS | 12 Jul, 2018, 10.46AM
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Alembic Pharmaceuticals Wednesday announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for lloperidone tablets, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg.

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Fanapt Tablets, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg, of Vanda Pharmaceuticals, Inc. lloperidone tablets are indicated for the treatment of schizophrenia inadults.

lloperidone Tablets have an estimated market size of US$ 128 million for twelve months ending December 2017 according to IQVIA.

Alembic now has a total of 74 ANDA approvals (65 final approvals and 9 tentative approvals) from USFDA.

Shares of the company gained Rs 7.1, or 1.34%, to trade at Rs 538.00. The total volume of shares traded was 708 at the BSE (10.33 a.m., Thursday).



Alembic Pharmaceuticals Limited   (Q,N,C,F)*

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