Ampyra

For multiple sclerosis (MS). NDA 22250, held by Merz. Dalfampridine.

As of Nov 13, 2026, NDA 22250 (Ampyra), held by Merz, was first approved by FDA on Jan 22, 2010, with 13 approved supplements and 0 published complete response letters.

First approved: Jan 22, 2010
Review: Priority
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

AMPYRA is indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA (dalfampridine) is a potassium channel blocker indicated to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed ( 1, 14 ).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jan 22, 2010	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ampyra10MG · tablet, extended release;oral	Dalfampridine	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Nov 18, 2021	Supplement 19Labeling · Standard review	Approved	Letter Label Medication Guide
Feb 24, 2021	Supplement 18Labeling · Standard review	Approved	Label Letter
Dec 19, 2019	Supplement 17Labeling · Standard review	Approved	Letter Label
Sep 29, 2017	Supplement 15Labeling · Standard review	Approved	Label Letter Letter
Oct 13, 2016	Supplement 13Labeling · Standard review	Approved	Letter Label
Sep 30, 2014	Supplement 1Manufacturing · Priority review	Approved	None posted
Aug 22, 2014	Supplement 10Manufacturing · Priority review	Approved	None posted
Jun 18, 2013	Supplement 8REMS	Approved	Letter
Jan 22, 2013	Supplement 6Labeling · Standard review	Approved	Letter Label
Dec 21, 2012	Supplement 7Labeling · Standard review	Approved	Label Letter
Jul 20, 2012	Supplement 4Labeling · Standard review	Approved	Letter Label
Jul 20, 2012	Supplement 3Labeling · Priority review	Approved	Label
Nov 17, 2011	Supplement 2REMS	Approved	Letter
Jan 22, 2010	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 22250
Drugs@FDA: Overview at FDA
Company: Merz Pharmaceuticals

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