FDA to Review Ready-to-Dilute Pemetrexed Formulation

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 30, 2017
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 30, 2017

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. 

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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.