Rizafilm

Treats migraine with or without aura. NDA 205394, held by Gensco. Rizatriptan Benzoate.

As of Nov 15, 2026, NDA 205394 (Rizafilm), held by Gensco, was first approved by FDA on Apr 14, 2023, with 3 approved supplements and 3 published complete response letters.

First approved: Apr 14, 2023
Review: Standard
Supplements approved: 3
Complete response letters: 3

What It's For

From the FDA-approved label (Indications and Usage)

RizaFilm is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age. Limitations of Use RizaFilm should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks. RizaFilm is not indicated for the preventive treatment of migraine. Safety and effectiveness of RizaFilm have not been established for cluster headache.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below


Feb 26, 2026	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 14, 2023	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter


Mar 24, 2020	RizaFilm (rizatriptan)Product Quality, Facility Inspections	Approved
Mar 28, 2019	Rizaport (rizatriptan)Product Quality, Rizaport, Facility Inspections	Approved
Jan 31, 2014	Rizaport (rizatriptan)Product Quality, Labeling, Facility Inspections	Approved

Products

2 strengths and forms


RizafilmEQ 10MG BASE · film;oral	Rizatriptan Benzoate	RxReference drug
RizafilmEQ 5MG BASE · film;oral	Rizatriptan Benzoate	RxReference drug

All 4 submissions, including labeling and manufacturing supplements


Feb 26, 2026	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 29, 2026	Supplement 7Labeling · Standard review	Approved	Label Letter
Dec 11, 2023	Supplement 2Labeling · Standard review	Approved	Letter Label
Apr 14, 2023	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 205394
Drugs@FDA: Overview at FDA
Company: Gensco

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