Neupro

Treats Parkinson's disease. NDA 21829, held by Ucb Inc. Rotigotine.

As of Nov 14, 2026, NDA 21829 (Neupro), held by Ucb Inc, was first approved by FDA on May 9, 2007, with 12 approved supplements and 0 published complete response letters.

First approved: May 9, 2007
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NEUPRO is a dopamine agonist indicated for the treatment of: Parkinson's disease Moderate-to-severe primary Restless Legs Syndrome 1.1 Parkinson's Disease (PD) NEUPRO is indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome (RLS) NEUPRO is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Apr 2, 2012	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Apr 2, 2012	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
May 9, 2007	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Patient Package Insert

Products

6 strengths and forms


Neupro2MG/24HR · film, extended release;transdermal	Rotigotine	RxReference drug
Neupro4MG/24HR · film, extended release;transdermal	Rotigotine	RxReference drug
Neupro6MG/24HR · film, extended release;transdermal	Rotigotine	RxReference drug
Neupro1MG/24HR · film, extended release;transdermal	Rotigotine	RxReference drug
Neupro3MG/24HR · film, extended release;transdermal	Rotigotine	RxReference drug
Neupro8MG/24HR · film, extended release;transdermal	Rotigotine	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Jul 12, 2021	Supplement 21Labeling · Standard review	Approved	Letter Label
Jul 12, 2021	Supplement 22Labeling · Standard review	Approved	Letter Label
Apr 24, 2020	Supplement 17Labeling · Standard review	Approved	Letter Label
Apr 3, 2020	Supplement 19Labeling	Approved	Label Letter
Jan 18, 2019	Supplement 16Labeling · Standard review	Approved	Label Letter
Nov 29, 2018	Supplement 15Labeling · Standard review	Approved	Letter Label
Jan 30, 2017	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 3, 2016	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 10, 2015	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 26, 2015	Supplement 7Labeling · Standard review	Approved	Label Letter
Apr 2, 2012	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Apr 2, 2012	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
May 9, 2007	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label Patient Package Insert

Identifiers

Application: NDA 21829
Drugs@FDA: Overview at FDA
Company: UCB

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