Alembic Pharmaceuticals Ltd. on Thursday announced receiving tentative approval from the United States Food and Drug Administration for Brexpiprazole tablets, which are used in the treatment of major depressive disorder and for treatment of schizophrenia.

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The company in an exchange filing stated that the tentative USFDA approval is for Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets in the strength of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product, Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, of Otsuka Pharmaceutical Co., Ltd. (Otsuka).

According to IQVIA data, Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have a market size of $1.6 billion for the 12 months to December 2022.

Brexpiprazole Tablets are used as adjunctive therapy to antidepressants for the treatment of major depressive disorder and schizophrenia.

Alembic Pharma has a cumulative total of 184 ANDA approvals (160 final approvals and 24 tentative approvals) from the USFDA.

The company manufactures and markets generic pharmaceutical products all over the world.

Earlier this week, the company received the final approval from USFDA for Prazosin Hydrochloride Capsules USP 1 mg, 2 mg, and 5 mg.

Alembic Pharma on Monday also announced that it has received final approval from USFDA for Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) pharmacy bulk vial. The injection is used for treatment of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric adenocarcinoma and pancreatic adenocarcinoma.

The company, on February 16 had received an Establishment Inspection Report (EIR) from the US FDA for its F-3 unit at Karkhadi following an inspection from August 18-30, 2022.

Shares of Alembic Pharma were trading at Rs 508.55 apiece, down 0.73 percent, on BSE at 9:48 am on Thursday.

(Edited by : Rukmani Krishna)