Impavido

NDA 204684, held by Eton. Miltefosine.

As of Nov 13, 2026, NDA 204684 (Impavido), held by Eton, was first approved by FDA on Mar 19, 2014, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 19, 2014
Review: Priority
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

IMPAVIDO (miltefosine) capsules are indicated in adults and pediatric patients 12 years of age and older weighing greater than or equal to 30 kg (66 lbs) for the treatment of:

Visceral leishmaniasis caused by Leishmania donovani.
Cutaneous leishmaniasis caused by Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis.
Mucosal leishmaniasis caused by Leishmania braziliensis. Limitations of Use:
Leishmania species studied in clinical trials evaluating IMPAVIDO were based on epidemiologic data.
There may be geographic variation in clinical response of the same Leishmania species to IMPAVIDO.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Mar 19, 2014	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Impavido50MG · capsule;oral	Miltefosine	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


Nov 2, 2026	Supplement 9Labeling · Standard review	Approved	Letter Label
Mar 14, 2025	Supplement 7Labeling · Standard review	Approved	Letter Letter Label
Mar 14, 2025	Supplement 8Labeling · Standard review	Approved	Letter Label Medication Guide
May 25, 2021	Supplement 6Labeling · Standard review	Approved	Label Letter
Jan 4, 2016	Supplement 3Manufacturing · Priority review	Approved	None posted
Nov 4, 2015	Supplement 2Manufacturing · Priority review	Approved	None posted
Apr 10, 2015	Supplement 1Manufacturing · Priority review	Approved	None posted
Mar 19, 2014	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 204684
Drugs@FDA: Overview at FDA
Company: Eton Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters