Industry

USFDA gives nod for Docetaxel Injection USP

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Docetaxel Injection, of Hospira.

The Health Master

March 1, 2023

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Last Updated on October 17, 2024 by The Health Master

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) single-dose vial, and 80 mg/8 mL (10 mg/mL) and 160 mg/16 mL (10 mg/mL) multiple-dose vials.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Docetaxel Injection, 20 mg/2 mL, 80 mg/8 mL, and 160 mg/16 mL (10 mg/mL), of Hospira.

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Docetaxcel Injections are indicated for breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of the head and neck.

Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) Single-Dose Vial, and 80 mg/8 mL (10 mg/mL) and 160 mg/16 mL (10 mg/mL) Multiple-Dose Vials, have an estimated market size of US$ 11 million for twelve months ending Dec 2022 according to IQVIA.

Alembic has a cumulative total of 181 ANDA approvals (158 final approvals and 23 tentative approvals) from USFDA.

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