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Fulphila Approval History

  • FDA approved: Yes (First approved June 4th, 2018)
  • Brand name: Fulphila
  • Generic name: pegfilgrastim-jmdb
  • Dosage form: Injection
  • Company: Mylan N.V.
  • Treatment for: Neutropenia Associated with Chemotherapy

Fulphila (pegfilgrastim-jmbd) is a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim) indicated to reduce the duration of febrile neutropenia in patients treated with chemotherapy.

Development History and FDA Approval Process for Fulphila

DateArticle
Jun  4, 2018Approval U.S. FDA Approves Fulphila (pegfilgrastim-jmdb), the First Biosimilar to Neulasta

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