Pentam

Treats pneumonia due to Pneumocystis carinii. NDA 19264, held by Fresenius Kabi USA. Pentamidine Isethionate.

As of Nov 14, 2026, NDA 19264 (Pentam), held by Fresenius Kabi USA, was first approved by FDA on Oct 16, 1984, with 19 approved supplements and 0 published complete response letters.

First approved: Oct 16, 1984
Review: Priority
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Pentam 300 (pentamidine isethionate for injection) is indicated for the treatment of pneumonia due to Pneumocystis carinii.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Oct 16, 1984	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Pentam300MG/VIAL · injectable;injection	Pentamidine Isethionate	RxReference drug

All 20 submissions, including labeling and manufacturing supplements


Jan 8, 2014	Supplement 32Manufacturing	Approved	None posted
Feb 16, 2013	Supplement 31Manufacturing	Approved	None posted
May 24, 2002	Supplement 23Manufacturing	Approved	None posted
Oct 24, 1997	Supplement 21Labeling · Standard review	Approved	None posted
Feb 26, 1997	Supplement 19Labeling · Standard review	Approved	None posted
Aug 27, 1996	Supplement 15Labeling	Approved	None posted
Mar 18, 1996	Supplement 18Labeling · Standard review	Approved	None posted
Jun 8, 1994	Supplement 17Manufacturing	Approved	None posted
May 31, 1994	Supplement 16Manufacturing	Approved	None posted
Feb 9, 1993	Supplement 13Labeling	Approved	None posted
Aug 16, 1989	Supplement 14Manufacturing	Approved	None posted
Nov 14, 1988	Supplement 12Manufacturing	Approved	None posted
Jun 12, 1987	Supplement 8Manufacturing	Approved	None posted
Jun 10, 1987	Supplement 3Manufacturing	Approved	None posted
Apr 9, 1987	Supplement 4Labeling	Approved	None posted
Oct 24, 1986	Supplement 7Manufacturing	Approved	None posted
Oct 24, 1986	Supplement 6Manufacturing	Approved	None posted
Oct 24, 1986	Supplement 5Manufacturing	Approved	None posted
Aug 6, 1985	Supplement 2Manufacturing	Approved	None posted
Oct 16, 1984	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 19264
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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