Alembic Pharma Gets Tentative ANDA Nod for lloperidone Tab | CORPORATE ETHOS

Alembic Pharma Gets Tentative ANDA Nod for lloperidone Tab

By: | July 11, 2018
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Jul 11: Gujarat-based Alembic Pharmaceuticals Ltd on 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 in adults,” the company said.

lloperidone Tablets have an estimated market size of $ 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.