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US FDA gives final approval to Alembic Pharma’s Paclitaxel injection

This is the first product approval for oncology injection from the company's F-2 Facility (oncology injectable) which recently completed the first FDA inspection

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The US Food and Drug Administration (FDA) has given the final approval to Alembic Pharma’s 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, a statement from Alembic pharma notified yesterday.

According to the statement, this is the first product approval for oncology injection from our F-2 Facility (oncology injectable) which recently completed the first FDA inspection.

Further, the statement said that the approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product 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 is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, it is indicated in combination with cisplatin for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin containing combination chemotherapy, added the statement.

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.

Paclitaxel injection has an estimated market size of $26 million for 12 months ending June 2022, according to IQVIA, the statment concluded.