Alembic Pharmaceuticals Limited on Thursday announced that it has received final approval from the US Food & Drug Administration (USFDA) 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.
According to the company, this is the first product approval for oncology injection from their F-2 Facility (Oncology Injectable) which recently completed the first USFDA inspection.
“The approved 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 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 and for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin containing combination chemotherapy,” the company said in a statement on Thursday.
It is also indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, 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 and for the second-line treatment of AIDS-related Kaposi’s sarcoma.
The pharma company also claimed that 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 during the clinical trial.
According to IQVIA, Paclitaxel Injection USP has an estimated market size of US$ 26 million for twelve months ending June 2022. Reportedly, Alembic has a cumulative total of 172 ANDA approvals (148 final approvals and 24 tentative approvals) from the USFDA.
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