Pemetrexed - Eagle Pharmaceuticals

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Drug Profile

Pemetrexed - Eagle Pharmaceuticals

Alternative Names: EP-5101; Pemetrexed RTD; RTD Pemetrexed Injection

Latest Information Update: 31 Oct 2017

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At a glance

  • Originator Eagle Pharmaceuticals
  • Class Antineoplastics; Benzamides; Glutamates; Hypoxanthines; Small molecules
  • Mechanism of Action Tetrahydrofolate dehydrogenase inhibitors; Thymidylate synthase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Mesothelioma; Non-small cell lung cancer

Most Recent Events

  • 27 Oct 2017 FDA issues tentative approval to pemetrexed injection 25 mg/mL for Non-small cell lung cancer (Metastatic disease, Late-stage disease, Second-line therapy or greater, Monotherapy), Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater), Non-small cell lung cancer (Combination therapy; Metastatic disease; Late-stage disease) and Mesothelioma (Combination therapy; Inoperable/Unresectable)
  • 28 Feb 2017 FDA assigns PDUFA action date of 30/10/2017 for Pemetrexed for Mesothelioma and Non-small cell lung cancer
  • 31 Dec 2016 Preregistration for Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (IV)
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