Amneal granted FDA nod for chemotherapy injection

• Generic drugmaker Amneal Pharmaceuticals (NYSE:AMRX) announced Wednesday that the FDA approved its Pemrydi RTU product as the first and only ready-to-use injectable of chemotherapy pemetrexed.
• The agency has approved the company’s 505(b)(2) New Drug Application (NDA) for Pemrydi RTU, allowing its use for non-squamous non-small cell lung cancer and malignant pleural mesothelioma as a combination therapy.
• Amneal (AMRX) expects to receive J-Code from the Centers for Medicare & Medicaid Services (CMS) to launch Pemrydi RTU in Q1 2024.
• “By eliminating formulation steps common with other pemetrexed products, we are improving provider efficiencies while reducing the risk for medication errors,” Harsher Singh, SVP of Amneal Biosciences, said.
• According to healthcare analytics firm IQVIA (IQV), the U.S. annual sales for pemetrexed reached $532M for the 12 months ending March 2023.

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