Alembic Pharma will get USFDA nod for bipolar despair drug, Well being Information, ET HealthWorld


Alembic Pharma gets USFDA nod for bipolar depression drugDrug agency Alembic Pharmaceuticals on Friday stated it has obtained last approval from the US well being regulator for Lurasidone Hydrochloride tablets, used to deal with bipolar depression.

The accepted product is therapeutically equal to the reference listed drug product (RLD) Latuda tablets of Sunovion Pharmaceuticals Inc.

The corporate has obtained approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug software (ANDA) Lurasidone Hydrochloride tablets within the strengths of 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg, Alembic Prescription drugs stated in a regulatory submitting.

Quoting IQVIA knowledge, Alembic Pharma stated Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg have an estimated market measurement of USD 3.7 billion for the twelve months ending December 2020.

Lurasidone Hydrochloride tablets are indicated for therapy of main depressive episodes related to bipolar I dysfunction (bipolar despair).

Alembic Pharma stated it has settled the case with Sunovion and can launch its generic as per the phrases of settlement.

Alembic now has a complete of 144 abbreviated new drug software (ANDA) approvals, together with 126 last approvals and 18 tentative approvals from the USFDA.

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