FDA to Review Ready-to-Dilute Pemetrexed Formulation
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Eagle's ready-to-dilute (RTD) Pemetrexed Injection 25mg/mL for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer and mesothelioma (in combination with cisplatin).
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 30, 2017 to complete its review of the NDA.
Eagle's pemetrexed injection is formulated as a ready-to-dilute liquid of 500mg in a multi-dose vial.
For more information visit Eagleus.com.