Alembic Pharmaceuticals’ Hypertension Pills gets US FDA Approval

HEALTHCARE

Alembic Pharmaceuticals Ltd announced that, Brexpiprazole tablets, which are used to treat schizophrenia and major depressive disorder, have received tentative approval from the United States Food and Drug Administration (FDA).

Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets in strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg have received tentative USFDA approval, according to the company’s exchange filing.

The approved ANDA is therapeutically equivalent to Otsuka Pharmaceutical Co., Ltd.’s reference listed drug product, Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. According to IQVIA data, the market for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg will be $1.6 billion in the year 2022. Brexpiprazole Tablets are used in conjunction with antidepressants to treat schizophrenia and major depressive disorder.

The US Food and Drug Administration (FDA) has granted Alembic Pharma 184 ANDA approvals, consisting of 160 final approvals and 24 tentative approvals. The business produces and sells generic pharmaceutical products worldwide. Prazosin Hydrochloride Capsules USP 1 mg, 2 mg, and 5 mg received final approval from the US Food and Drug Administration earlier this week.

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Additionally, Alembic Pharma announced that the pharmacy bulk vial containing Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) had received final FDA approval. Patients with colon and rectal adenocarcinoma, breast adenocarcinoma, gastric adenocarcinoma, and pancreatic adenocarcinoma are treated with the injection.

Following an inspection that took place from August 18-30, 2022, the company received an Establishment Inspection Report (EIR) from the US Food and Drug Administration on February 16 for its F-3 unit at Karkhadi.