Alembic Pharma Gets USFDA Nod For Generic Injection To Treat Cancer
Alembic Pharmaceuticals has received final approval from U.S. health regulator for its generic version of Paclitaxel injection.
Alembic Pharmaceuticals Ltd. on Thursday said it has received final approval from the U.S. health regulator for its generic version of Paclitaxel injection used in the treatment of certain types of cancer.
The U.S. Food & Drug Administration approved the drug maker's abbreviated new drug application 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 a subsequent therapy for the treatment of advanced carcinoma of the ovary.
It is also used 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 $26 million (Rs 214.05 crore) for 12 months ended June 30, 2022.