Alembic Pharmaceuticals gets FDA final approval for Paclitaxel Injection USP

Alembic Pharmaceuticals Limited has secured final approval 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 from the US Food & Drug Administration (FDA).

According to the Indian pharma company, this is the maiden product approval for oncology injection from its F-2 facility (Oncology Injectable) which recently underwent its first FDA inspection.

The approved product is a generic version of 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).

Alembic Pharmaceuticals gets FDA final approval for Paclitaxel Injection USP. Photo courtesy of Alembic Pharmaceuticals Limited.

Paclitaxel Injection, USP is approved as subsequent therapy for treating advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP has the approval to be used in combination with cisplatin.

It is also indicated for the adjuvant treatment of node-positive breast cancer sequentially administered to standard doxorubicin containing combination chemotherapy.

According to IQVIA, Paclitaxel Injection USP has an estimated market size of $26 million for 12 months ending June 2022.

Alembic Pharmaceuticals has a cumulative total of 172 ANDA approvals from the FDA, which includes 148 final approvals and 24 tentative approvals.