The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Paclitaxel injection of strengths 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 USFDA inspection,” Alembic said in a regulatory filing.
Paclitaxel injection is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary.
Also, it is indicated in combination with cisplatin as first-line therapy for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin containing combination chemotherapy, it added.
The company, citing IQVIA data, said Paclitaxel injection has an estimated market size of USD 26 million for 12 months ended June 30, 2022.