Drug agency Alembic Pharmaceuticals on Friday mentioned it has acquired last approval from the US well being regulator for Lurasidone Hydrochloride tablets, used to deal with bipolar melancholy.
The authorized product is therapeutically equal to the reference listed drug product (RLD) Latuda tablets of Sunovion Prescribed drugs Inc.
The corporate has acquired approval from the US Meals and Drug Administration (USFDA) for its abbreviated new drug utility (ANDA) Lurasidone Hydrochloride tablets within the strengths of 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg, Alembic Pharmaceuticals mentioned in a regulatory submitting.
Quoting IQVIA knowledge, Alembic Pharma mentioned Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg have an estimated market dimension 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 melancholy).
Alembic Pharma mentioned 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 utility (ANDA) approvals, together with 126 last approvals and 18 tentative approvals from the USFDA.
(Solely the headline and movie of this report could have been reworked by the Enterprise Customary workers; the remainder of the content material is auto-generated from a syndicated feed.)