505(b)(2) NDA Approval granted from FDA for PEMRYDI RTU®, a Ready-to-Use Oncology Injectable
“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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