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.