Visceral Leishmaniasis

• FDA approval · 2022-03-17
  FDA Approved: PENTAMIDINE ISETHIONATE — Original Application (XGen Pharmaceuticals DJB, Inc.)

  FDA approved the original application for Pentamidine isethionate (generic) from XGen Pharmaceuticals DJB, Inc., authorizing its U.S. market…

• FDA approval · 2021-05-25
  FDA Approved: IMPAVIDO — Supplemental Application (Profounda, Inc.)

  The FDA approved a supplemental application for IMPAVIDO (miltefosine) filed by Profounda, Inc.

• FDA approval · 2019-04-24
  FDA Approved: PENTAMIDINE ISETHIONATE — Original Application (Seton Pharmaceuticals)

  FDA approved pentamidine isethionate in an Original Application by Seton Pharmaceuticals. It is indicated for Pneumocystis jirovecii pneumon…

• FDA approval · 2016-01-04
  FDA Approved: IMPAVIDO — Supplemental Application (Profounda, Inc.)

  FDA approved a supplemental application for IMPAVIDO (miltefosine) from Profounda, Inc. under NDA204684, expanding its approved use. This ac…

• FDA approval · 2015-04-10
  FDA Approved: IMPAVIDO — Supplemental Application (Profounda, Inc.)

  FDA approved a supplemental application for IMPAVIDO (miltefosine) filed by Profounda, Inc.

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• FDA approval · 2014-03-19
  FDA Approved: IMPAVIDO — Original Application (Profounda, Inc.)

  FDA approved IMPAVIDO (miltefosine) through Profounda, Inc. via Original Application (NDA204684) for visceral leishmaniasis and post-kala-az…