Amneal receives 505(b)(2) NDA approval from FDA for Pemrydi RTU, a ready-to-use oncology injectable.
Amneal Pharmaceuticals, Inc. announced the 505(b)(2) New Drug Application (NDA) approval from the 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.
“We believe PEMRYDI RTU, the first ready-to-use version of a key oncology injectable, will offer a meaningful advantage in this improved presentation. By eliminating formulation steps common with other pemetrexed products, we are improving provider efficiencies while reducing the risk for medication errors. This approval represents another high-value product for our growing injectables portfolio which we expect to launch with a J-code for PEMRYDI RTU,” said Harsher Singh, SVP of Amneal Biosciences.
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