Eugia Pharma receives USFDA Approval for Pemetrexed for Injection

Aurobindo Pharma Limited is pleased to announce that its wholly owned subsidiary company, Eugia Pharma Specialties Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Pemetrexed for Injection, 100 mg, 500mg and 1000mg. Pemetrexed for Injection USP, 100 mg/vial and 500 mg/vial, Single-Dose Vials, to be bioequivalent and therapeutically equivalent to the RLD, Alimta for Injection, 100 mg/vial and 500 mg/vial of Eli Lilly. The product is being launched immediately.

The approved product has an estimated market size of US$ 1272 million for the twelve months ending March 2022, according to IQVIA. 

This is the 139th ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products. 

Pemetrexed for injection is indicated for the treatment of Antineoplastics (medications used to treat cancer)

·         With pembrolizumab and platinum chemotherapy, for initial treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations.

·         With cisplatin, for initial treatment of patients with locally advanced or metastatic, non-squamous, nonsmall cell lung cancer (NSCLC).

·         Alone, as maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

·         Alone, for treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. 

Limitations: Not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.

Corporate Comm India (CCI Newswire)