Alembic Pharmaceuticals Receives USFDA provisional Approval for Bosutinib Tablets

Alembic Pharmaceuticals has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Bosutinib Tablets in 100 mg and 500 mg strengths.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif Tablets, 100 mg and 500 mg, of PF Prism C.V. Bosutinib Tablets are indicated for the treatment of a certain type of leukemia called Philadelphia chromosome-positive chronic myelogenous leukemia.

The estimated market size for Bosutinib Tablets, 100 mg and 500 mg, is $275 million for the 12 months ending March 2024, according to IQVIA

Read the full Press Release 

Bosutinib Tablets Treatment Usages 

The Bosutinib Tablets are drugs that are used on Cancer patients who are in the various stages of the treatment.

• Bosutinib tablets are used to treat adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML).
• The recommended starting dose of bosutinib is 500 mg taken orally once daily with food.
• In patients who do not reach a complete hematologic response by week 8 or a complete cytogenetic response by week 12, and who do not have severe side effects, the dose may be increased to 600 mg once daily with food.
• The dosage may need to be adjusted based on side effects. For example, the dose may be reduced to 400 mg once daily if there are issues with elevated liver enzymes or severe diarrhea.
• Bosutinib works by inhibiting certain enzymes (kinases) that promote the growth of CML cells. It is considered a targeted therapy for CML patients who are resistant or intolerant to prior treatments.

In summary, bosutinib tablets are an oral targeted cancer medication used primarily to treat adults with various phases of Philadelphia chromosome-positive chronic myelogenous leukemia. The standard starting dose is 500 mg once daily with food, with the potential for dose escalation or reduction based on individual patient response and tolerability.

Read the FDA Data about the drug here.

Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited is a leading Indian pharmaceutical company with a history dating back to 1907. As a vertically integrated research and development company, Alembic manufactures and markets generic pharmaceutical products globally from its state-of-the-art facilities approved by regulatory authorities like the USFDA.

Headquartered in India, Alembic is a publicly listed company and a pioneer in branded generics in the country, with well-recognized brands marketed through a team of over 5,000 people.