Pharma Focus America

Amneal Granted FDA Approval for PEMRYDI RTU®, a Ready-to-Use Oncology Injectable, through 505(b)(2) NDA Pathway

Thursday, June 15, 2023

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) announced today that it has received FDA approval for PEMRYDI RTU®, a ready-to-use oncology injectable, through the 505(b)(2) New Drug Application (NDA) pathway. This approval marks a significant milestone as PEMRYDI RTU® becomes the first and only presentation of pemetrexed for injection that does not require reconstitution, dilution, or refrigeration. The product will be available in three vial sizes: 100mg/10mL, 500mg/50mL, and 1,000mg/100mL. Amneal plans to launch PEMRYDI RTU® in the first quarter of 2024 and has obtained a J-Code from the Centers for Medicare & Medicaid Services.

PEMRYDI RTU® is expected to offer a notable advantage with its improved presentation as a ready-to-use version of a key oncology injectable. It eliminates the need for formulation steps commonly required with other pemetrexed products, thereby enhancing provider efficiency and reducing the risk of medication errors. The approval of PEMRYDI RTU® further strengthens Amneal's injectables portfolio and underscores the company's commitment to delivering high-value products. Harsher Singh, SVP of Amneal Biosciences, expressed confidence in the approval and highlighted the significance of launching PEMRYDI RTU® with a J-code.

Indicated uses for PEMRYDI RTU® include its combination with pembrolizumab and platinum chemotherapy for the initial treatment of metastatic non-squamous non-small cell lung cancer in patients without EGFR or ALK genomic tumor aberration. It is also indicated for initial treatment, in

combination with cisplatin, of patients with unresectable malignant pleural mesothelioma or those who are not suitable candidates for curative surgery.

PEMRYDI RTU® may have certain adverse effects, including myelosuppression, renal failure, skin toxicity, and radiation recall. For detailed prescribing information, please refer to the package insert available with the product.

According to IQVIA®, pemetrexed achieved annual sales of $532 million in the United States for the 12-month period ending in March 2023.

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