- Source : Press Release
- Date : 2022-05-25
- Event type : Approved
- Companies : Aurobindo Pharma Ltd.
Aurobindo Pharma Receives USFDA Approval for Pemetrexed for Injection, 100 Mg, 500 Mg, and 1,000 Mg
Aurobindo 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.