Alembic Pharma gets US FDA approval for paclitaxel injection USP

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for paclitaxel injection USP, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) multiple-dose vials. This is the first product approval for oncology injection from our F-2 Facility (oncology injectable) which recently completed the first US FDA inspection. The nod by ANDA is therapeutically equivalent to the reference listed drug product (RLD), Taxol injection, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL).

Paclitaxel injection, USP is indicated

i) as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel injection, USP is indicated in combination with cisplatin.

ii) for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin containing combination chemotherapy. In the clinical trial, there was an overall favourable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumours, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor negative tumours.

iii) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

iv) in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.

v) for the second-line treatment of AIDS-related Kaposi’s sarcoma.

Paclitaxel Injection USP, has an estimated market size of US$ 26 million for twelve months ending June 2022 according to IQVIA. Alembic has a cumulative total of 172 ANDA approvals (148 final approvals and 24 tentative approvals) from US FDA.