Alembic Pharma gets USFDA tentative Nod for Brexpiprazole Tablets

Alembic Pharma Q1FY24 Results: Consolidated PAT of Rs. 120.60 Cr

Key Points of Nod:

  • Alembic Pharmaceuticals Limited has received tentative approval from the USFDA for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets.
  • Brexpiprazole Tablets are available in doses of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.
  • The USFDA has declared that the ANDA is therapeutically equivalent to Otsuka Pharmaceutical’s Rexulti Tablets.
  • Brexpiprazole Tablets are indicated for treating major depressive disorder and schizophrenia as an adjunctive therapy to antidepressants.
  • Unexpired exclusivities for the RLD limit the use of Brexpiprazole Tablets for other treatments.
  • According to IQVIA, Brexpiprazole Tablets are projected to reach a market size of approximately US$ 1.6 billion by December 2022.
  • The achievement of 184 ANDA approvals, including 160 final approvals and 24 tentative approvals, highlights Alembic’s commitment to providing high-quality and cost-effective medications to US consumers.
  • Patients can expect to have access to a broader range of safe and effective treatments as Alembic continues to expand its portfolio of approved drugs.

Details of Nod:

Alembic Pharmaceuticals Limited has announced that the US Food & Drug Administration (USFDA) has granted tentative approval for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, available in doses of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg.

The approval makes the ANDA therapeutically equivalent to Otsuka Pharmaceutical’s Rexulti Tablets, also available in the same doses. Brexpiprazole Tablets are indicated for treating major depressive disorder and schizophrenia as an adjunctive therapy to antidepressants. However, it may not be used for other treatments due to the unexpired exclusivities for the RLD. Refer to the label for the full indication.

According to IQVIA, Brexpiprazole Tablets in various strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, are projected to reach an impressive market size of approximately US$ 1.6 billion by December 2022. This news highlights the significant growth potential of this medication and the demand for it in the pharmaceutical market. Stay up-to-date with the latest developments in the healthcare industry by following our blog.

The USFDA has granted Alembic, a leading pharmaceutical company, a total of 184 ANDA approvals, which includes 160 final approvals and 24 tentative approvals. This noteworthy achievement highlights Alembic’s dedication to providing high-quality and cost-effective medications to consumers in the United States. With an expanding portfolio of approved drugs, patients can expect to have access to a broader range of safe and effective treatments.

About Alembic Pharma:

Alembic Pharmaceuticals is in the business of development, manufacturing, and marketing of Pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients.
The company has 3 R&D and 5 manufacturing facilities.

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