Instant Report

Date: 09-Jul-2021

Alembic Pharmaceuticals Gets USFDA Nod For Anti-depressant Drug

Drug firm Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator for Desipramine Hydrochloride tablets used in the treatment of depression. The approved product is therapeutically equivalent to the reference listed drug product Norpramin tablets of Validus Pharmaceuticals LLC.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Desipramine Hydrochloride tablets USP in the strength of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, Alembic Pharmaceuticals said in a regulatory filing.

Quoting IQVIA data, Alembic Pharma said Desipramine Hydrochloride Tablets have an estimated market size of USD 7 million for twelve months ending March 2021.

Alembic has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from the USFDA.