Alembic Pharmaceuticals Secures USFDA Approval for Nelarabine Injection

Alembic Pharmaceuticals Limited today announced a significant milestone with the US Food and Drug Administration’s (USFDA) final approval of its Abbreviated New Drug Application (ANDA) for Nelarabine Injection, 250 mg/50 mL (5 mg/mL). This single-dose vial formulation is therapeutically equivalent to Sandoz Inc.’s Arranon Injection.

Nelarabine, a nucleoside metabolic inhibitor, is a critical treatment for patients with T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma, particularly in adult and paediatric populations aged one year and older who have experienced treatment resistance or relapse following at least two chemotherapy regimens. The specific indications for use can be found on the product label.

With an estimated market size of US$ 23 million for the twelve months ending March 2024, as per IQVIA data, Nelarabine Injection represents a substantial market opportunity for Alembic. This latest approval brings the company’s cumulative total of ANDA approvals from the USFDA to an impressive 211, comprising 183 final approvals and 28 tentative approvals.

Alembic’s consistent track record of securing USFDA approvals underscores its commitment to providing high-quality, affordable generic medications to patients in need. This achievement further solidifies the company’s position as a leading player in the global pharmaceutical market.

Previously, the company successfully completed the United States Food and Drug Administration (USFDA) inspection for its Oral Solid Formulation Facility (F-I) located at Panelav. This was a scheduled GMP inspection and was successfully completed without any Form 483 observation. The inspection was conducted from July 17 to July 26, 2024.

About Alembic Pharmaceuticals Ltd

Alembic Pharmaceuticals Limited, a vertically integrated research and development

pharmaceutical company, has been at the forefront of healthcare since 1907. Alembic’s state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. Alembic is one of the leaders in branded generics in India.

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