New & Noteworthy

September 2023

Ready-to-Use Oncology Injectable

Amneal Pharmaceuticals

Amneal Pharmaceuticals announces the US FDA 505(b)(2) new drug application approval for Pemrydi ready-to-use. This product is a ready-to-use presentation of pemetrexed for injection and does not require reconstitution, dilution, or refrigeration. This injectable will be available in three vial sizes: 100 mg/10 mL, 500 mg/50 mL, and 1,000 mg/100 mL. This injectable is indicated, in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberration and for initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

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