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Eugia Pharma Receives USFDA Approval for Pemetrexed for Injection, 100 mg, 500 mg, and 1,000 mg

Published: May 25, 2022

Eugia Pharma Limited is pleased to announce that the company has received approval from the US Food & Drug Administration (USFDA) to manufacture and market Pemetrexed for Injection, 100 mg, 500 mg, and 1,000 mg.

Indications for this product include:

  • With pembrolizumab and platinum chemotherapy, for initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations.
  • With cisplatin, for initial treatment of patients with locally advanced or metastatic, non-squamous, non-small 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.

Refer to package insert for full prescribing information.