Amneal Receives NDA Approval from the US FDA for Pemrydi RTU
- The US FDA has approved a 505(b)(2) NDA for Pemrydi RTU, the first ready-to-use presentation of pemetrexed indicated for use in combination with Keytruda and Pt-based CT for metastatic nonsq. NSCLC without EGFR or ALK tumor aberrations, and in combination with cisplatin for patients with malignant pleural mesothelioma
- The inj. does not require reconstitution, dilution, or refrigeration. It will be available in three vial sizes: 100mg/10mL; 500mg/50mL; and 1000mg/100mL
- Additionally, the company is expected to launch the product in Q1’24 with a J-Code from the Centers for Medicare & Medicaid Services
Ref: Businesswire | Image: Amneal
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