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This is the 19th product to be approved (including 3 tentative approvals) for Eugia. Aurobindo now has a total of 482 ANDA approvals (453 Final approvals and 29 tentative approvals) from USFDA
Alembic Pharma gets USFDA approval for bipolar depression drug Drug firm Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for Lurasidone Hydrochloride tablets, used to treat bipolar depression. The approved product is therapeutically equivalent to the reference listed drug product (RLD) Latuda tablets of Sunovion Pharmaceuticals Inc. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Lurasidone Hydrochloride tablets in the strengths of 20 mg, 40 mg, 60 mg, 80 mg, a...
The approved product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Deltasone tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co.