Pemrydi RTU (pemetrexed injection) / Amneal - LARVOL DELTA

Amneal Launches PEMRYDI RTU, the First Ready-to-Use Version of Important Oncology Injectable Medicine (Businesswire) - "Amneal Pharmaceuticals, Inc...announced the launch of PEMRYDI RTU, the first and only ready-to-use presentation of pemetrexed for injection. This product does not require reconstitution, dilution, or refrigeration, which is different than other versions of pemetrexed for injection....PEMRYDI 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 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....According to IQVIA, U.S. annual sales for pemetrexed for the 12 months ended February 2024 were $287 million."

Launch • Sales • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Amneal Receives 505(b)(2) NDA Approval from FDA for PEMRYDI RTU, a Ready-to-Use Oncology Injectable (Businesswire) - "Amneal Pharmaceuticals, Inc...announced the 505(b)(2) New Drug Application (NDA) approval from the U.S. Food and Drug Administration ('FDA') for PEMRYDI RTU^®. This product is the first and only 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: 100mg/10mL; 500 mg/50mL; and 1,000mg/100mL. The Company expects to launch this product in the first quarter of 2024 with a J-Code from the Centers for Medicare & Medicaid Services....PEMRYDI 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 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."

Launch US • NDA • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Solid Tumor