USFDA Tentative Approval granted for Bosutinib Tablets

Bosutinib tablets target this specific abnormality, offering a targeted treatment approach.

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USFDA Drug product Approval
USFDA Approval

Last Updated on July 12, 2024 by The Health Master

Bosutinib Tablets

Alembic Pharmaceuticals Ltd. (Alembic) has achieved a significant milestone with the tentative approval of its Bosutinib Tablets by the U.S. Food and Drug Administration (USFDA).

This is a major win for both Alembic and patients battling Philadelphia chromosome-positive chronic myelogenous leukemia (CML).

Bosutinib Tablets: A Generic Option for CML Treatment

The approved Bosutinib Tablets come in two strengths: 100 mg and 500 mg.

They are considered therapeutically equivalent to Bosulif Tablets, the reference drug offered by PF Prism C.V. (affiliated with Pfizer Inc.).

This tentative approval paves the way for Alembic to potentially launch a generic version of Bosutinib in the U.S., offering a more affordable treatment option for CML patients.

Addressing a High-Demand Market

Chronic Myelogenous Leukemia (CML) is a type of blood cancer that affects the production of white blood cells.

Philadelphia chromosome-positive CML is a specific subtype with a distinct genetic abnormality.

Bosutinib tablets target this specific abnormality, offering a targeted treatment approach.

Alembic’s Bosutinib tablets, with USFDA approval, have the potential to disrupt the market and make CML treatment more affordable for a wider range of patients.

Building on a Strong Track Record

This tentative approval from the USFDA further strengthens Alembic’s position as a leading generic drug manufacturer.

The company boasts a cumulative total of 206 ANDA approvals from the USFDA, including 179 final approvals and 27 tentative approvals like this one.

This demonstrates Alembic’s commitment to developing high-quality generic medications that meet the strictest regulatory standards.

The Road Ahead

While this is a significant step forward, it’s important to note that the approval is tentative.

Alembic will need to complete any post-approval requirements set forth by the USFDA before officially launching Bosutinib tablets in the U.S. market.

However, this tentative approval is a positive indication and brings Alembic closer to offering a more affordable treatment option for CML patients in the United States.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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