FDA OKs Amneal’s Pemrydi

FDA has approved an Amneal Pharmaceuticals 505(b)(2) for Pemrydi RTU, a ready-to-use formulation of pemetrexed for injection that does not require reconstitution, dilution, or refrigeration. The injectable will be available in three vial sizes: 100mg/10mL; 500 mg/50mL; and 1,000mg/100mL. “By eliminating formulation steps common with other pemetrexed products, we are improving provider efficiencies while reducing the risk for medication errors,” the company says.

Pemryrdi RTU 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. It is also used as initial treatment, in combination with cisplatin, in patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.