Drugs Pharma

Alembic gets USFDA nod for oncology injection Paclitaxel

Alembic drug approval

HQ Team

October 27, 2022: Alembic Pharmaceuticals, an Indian maker of generic drugs, announced it had received USFDA’s final approval for Paclitaxel injection multi-dose vials for use in oncology.

The company’s 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 were approved by the US Food & Drug Administration (USFDA), according to a BSE filing

Paclitaxel is the first product approved for oncology injection from the company’s 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).


An abbreviated new drug application (ANDA) contains data submitted to the FDA for a generic drug product’s review and potential approval. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower-cost alternative to the brand-name drug it references.

Paclitaxel Injection USP can be used as subsequent therapy for treating advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP can be used with cisplatin and for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.

The United States Pharmacopeia National Formulary (USP-NF) includes over 5000 quality standards for medicines, both chemical and biological; active pharmaceutical ingredients (APIs); and excipients (inactive ingredients). It is the most comprehensive source for medicine quality standards in the world.

‘Favourable effect’

Alembic stated that 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.”

The injection also favoured breast cancer treatment 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. “

With cisplatin, it can be the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery or radiation therapy and 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 USFDA. 

Alembic Pharmaceuticals Limited, headquartered in India, is a publicly listed company that manufactures and markets generic pharmaceutical products globally.

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