Alembic Pharma bags USFDA nod for cancer injection Doxorubicin Hydrochloride Liposome

Vadodara: Pharmaceutical firm, 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) for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation.

Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi’s Sarcoma, and Multiple Myeloma.

Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2mg/mL) Single-Dose Vials have an estimated market size of US$ 29 million for twelve months ending March 2025 according to IQVIA.

Alembic has a cumulative total of 224 ANDA approvals (201 final approvals and 23 tentative approvals) from USFDA.

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This latest nod follows two other recent approvals secured by Alembic in May.

The company received final USFDA approval for its ANDA Bosutinib Tablets, 100 mg and 500 mg, 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. USFDA also approved Amlodipine and Atorvastatin Tablets, used to treat high blood pressure.

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