Alembic Pharma bags USFDA okay for blood cancer drug Bosutinib
Vadodara: Alembic Pharmaceuticals Limited has announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bosutinib Tablets, 100 mg and 500 mg.
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 adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.
Bosutinib Tablets, 100 mg and 500 mg have an estimated market size of US$ 291 million for twelve months ending March 2025 according to IQVIA
Alembic has a cumulative total of 223 ANDA approvals (200 final approvals and 23 tentative approvals) from USFDA.
Medical Dialogues team had earlier reported that the Company had also received USFDA nod for its ANDA for Nelarabine Injection, 250 mg/50 mL (5 mg/mL) (Single-Dose Vial). This nucleoside metabolic inhibitor is indicated for the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Read also: Alembic Pharma bags USFDA final nod for cancer injection Nelarabine
Headquartered in India, Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
