Mumbai, Oct 27: Pharma major Alembic Pharma on Thursday said it has received final approval from the US Food and 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.
This is the first product approval for oncology injection from our 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 i) 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. ii) for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin containing combination chemotherapy.
Paclitaxel Injection USP has an estimated market size of $ 26 million for 12 months ending June 2022.
(UNI)
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