Skip to Content

Impavido Approval History

  • FDA approved: Yes (First approved March 19th, 2014)
  • Brand name: Impavido
  • Generic name: miltefosine
  • Dosage form: Capsules
  • Company: Paladin Labs Inc.
  • Treatment for: Leishmaniasis

Impavido (miltefosine) is an oral alkylphosphocholine antiparasitic for the treatment of leishmaniasis.

Development History and FDA Approval Process for Impavido

Mar 19, 2014Approval FDA Approves Impavido to Treat Tropical Disease Leishmaniasis
Nov 13, 2013Paladin Announces Extension of the Impavido PDUFA Date by Three Months

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.