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Alembic Pharma gets USFDA nod for cancer injection Paclitaxel

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-10-27T11:36:45+05:30  |  Updated On 27 Oct 2022 6:35 AM GMT
Alembic Pharma gets USFDA nod for cancer injection Paclitaxel

Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

Vadodara: Drugmaker Alembic Pharmaceuticals Limited today announced that the company has received final approval from the US Food & 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...

Vadodara: Drugmaker Alembic Pharmaceuticals Limited today announced that the company has received final approval from the US Food & 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. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, 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 tumors.

iii) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

iv) in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.

v) for the second-line treatment of AIDS-related Kaposi's sarcoma.

Paclitaxel Injection USP has an estimated market size of US$ 26 million for twelve months ending June 2022, according to IQVIA. Alembic has a cumulative total of 172 ANDA approvals (148 final approvals and 24 tentative approvals) from the USFDA.

Read also: Alembic Pharma subsidiary bags USFDA nod for Adapalene, Benzoyl peroxide topical gel

alembic pharma alembic pharma news USFDA Paclitaxel Injection Taxol Injection breast cancer cisplatin AIDS sarcoma breast cancer injection 
Ruchika Sharma
Ruchika Sharma

    M.Com

    Ruchika joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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