Neoprofen

For an asymptomatic PDA. NDA 21903, held by Recordati Rare. Ibuprofen Lysine.

As of Nov 14, 2026, NDA 21903 (Neoprofen), held by Recordati Rare, was first approved by FDA on Apr 13, 2006, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 13, 2006
Review: Priority
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ibuprofen Lysine is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 13, 2006	Original applicationNew active ingredient · Priority review	Approved	Review Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
NeoprofenEQ 20MG BASE/2ML (EQ 10MG BASE/ML) · injectable;intravenous	Ibuprofen Lysine	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Oct 25, 2023	Supplement 14Labeling · Standard review	Approved	Label
Mar 26, 2021	Supplement 12Labeling · Standard review	Approved	Letter Label
Aug 14, 2019	Supplement 11Labeling · Standard review	Approved	Letter
Oct 16, 2017	Supplement 10Labeling · Standard review	Approved	Letter Label
Jan 13, 2016	Supplement 9Labeling · Standard review	Approved	Label Letter
Dec 3, 2013	Supplement 8Labeling · Standard review	Approved	Letter Label
Feb 28, 2013	Supplement 7Manufacturing · Priority review	Approved	None posted
Dec 22, 2009	Supplement 4Labeling · Standard review	Approved	Label Letter
Sep 12, 2008	Supplement 3Labeling · Standard review	Approved	Letter
Apr 13, 2006	Original applicationNew active ingredient · Priority review	Approved	Review Label

Identifiers

Application: NDA 21903
Drugs@FDA: Overview at FDA
Company: Recordati Rare Diseases

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