Nipent

NDA 20122, held by Hospira Inc. Pentostatin.

As of Nov 13, 2026, NDA 20122 (Nipent), held by Hospira Inc, was first approved by FDA on Oct 11, 1991, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 11, 1991
Review: Priority
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Sep 29, 1993	Supplement 1Efficacy (new indication or use)	Approved	None posted
Oct 11, 1991	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nipent10MG/VIAL · injectable;injection	Pentostatin	RxReference drug

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 3, 2025	Supplement 21Labeling · Standard review	Approved	Label Letter
Oct 28, 2019	Supplement 15Labeling · Standard review	Approved	Letter Label
Dec 29, 2015	Supplement 13Manufacturing · Priority review	Approved	None posted
Jun 20, 2013	Supplement 12Manufacturing · Priority review	Approved	None posted
Sep 22, 2009	Supplement 10Manufacturing	Approved	None posted
May 23, 2002	Supplement 7Manufacturing · Priority review	Approved	None posted
Aug 2, 2001	Supplement 6Manufacturing · Priority review	Approved	None posted
Oct 8, 1998	Supplement 4Manufacturing · Priority review	Approved	None posted
Dec 24, 1997	Supplement 3Manufacturing · Priority review	Approved	None posted
Jul 19, 1994	Supplement 2Labeling · Standard review	Approved	None posted
Sep 29, 1993	Supplement 1Efficacy (new indication or use)	Approved	None posted
Oct 11, 1991	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20122
Drugs@FDA: Overview at FDA
Company: Hospira

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