Ruzurgi

NDA 209321, held by Jacobus Pharm Co Inc. Amifampridine.

As of Nov 14, 2026, NDA 209321 (Ruzurgi), held by Jacobus Pharm Co Inc, was not approved, with 0 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 0
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below


Feb 1, 2022	Original applicationNew active ingredient · Priority review	Tentative approval	Letter
May 6, 2019	Original applicationEfficacy (new indication or use) · Priority review	Tentative approval	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ruzurgi10MG · tablet;oral	Amifampridine	None (tentative approval)Reference drug

All 3 submissions, including labeling and manufacturing supplements


Feb 1, 2022	Original applicationNew active ingredient · Priority review	Tentative approval	Letter
Feb 1, 2022	Supplement 1Labeling · Standard review	Tentative approval	None posted
May 6, 2019	Original applicationEfficacy (new indication or use) · Priority review	Tentative approval	Letter

Identifiers

Application: NDA 209321
Drugs@FDA: Overview at FDA
Company: Jacobus Pharmaceutical Company

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