Peganone

NDA 10841, held by Recordati Rare. Ethotoin.

As of Nov 14, 2026, NDA 10841 (Peganone), held by Recordati Rare, was first approved by FDA on Apr 22, 1957, with 16 approved supplements and 0 published complete response letters.

First approved: Apr 22, 1957
Review: Priority
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Apr 22, 1957	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Peganone250MG · tablet;oral	Ethotoin	DiscontinuedReference drug
Peganone500MG · tablet;oral	Ethotoin	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Feb 27, 2017	Supplement 25Manufacturing	Approved	None posted
Jan 23, 2013	Supplement 24Manufacturing · Priority review	Approved	None posted
May 31, 2011	Supplement 23REMS	Approved	Letter
Jun 7, 2010	Supplement 22Labeling · Standard review	Approved	Medication Guide Letter Label
Apr 23, 2009	Supplement 21Labeling	Approved	Letter Label
Feb 2, 2007	Supplement 20Labeling · Standard review	Approved	Label Letter
Sep 26, 2003	Supplement 13Labeling	Approved	Letter
Sep 26, 2003	Supplement 14Labeling · Standard review	Approved	Letter
Dec 10, 2002	Supplement 17Manufacturing · Priority review	Approved	None posted
Apr 4, 2002	Supplement 16Manufacturing · Priority review	Approved	None posted
May 13, 1998	Supplement 15Manufacturing · Priority review	Approved	None posted
Nov 13, 1984	Supplement 12Manufacturing · Priority review	Approved	None posted
Oct 28, 1983	Supplement 11Manufacturing · Priority review	Approved	None posted
Nov 4, 1982	Supplement 10Manufacturing · Priority review	Approved	None posted
Jul 12, 1982	Supplement 9Manufacturing · Priority review	Approved	None posted
Feb 5, 1980	Supplement 5Manufacturing · Priority review	Approved	None posted
Apr 22, 1957	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 10841
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