Vyvanse

NDA 208510, held by Takeda Pharms USA. Lisdexamfetamine Dimesylate.

As of Nov 13, 2026, NDA 208510 (Vyvanse), held by Takeda Pharms USA, was first approved by FDA on Jan 28, 2017, with 8 approved supplements and 0 published complete response letters.

First approved: Jan 28, 2017
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VYVANSE is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Moderate to severe binge eating disorder (BED) in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Jul 29, 2021	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 28, 2017	Original applicationNew dosage form · Standard review	Approved	Review Letter Label Pediatric Medical Review

Products

6 strengths and forms


Vyvanse10MG · tablet, chewable;oral	Lisdexamfetamine Dimesylate	RxReference drug
Vyvanse20MG · tablet, chewable;oral	Lisdexamfetamine Dimesylate	RxReference drug
Vyvanse30MG · tablet, chewable;oral	Lisdexamfetamine Dimesylate	RxReference drug
Vyvanse40MG · tablet, chewable;oral	Lisdexamfetamine Dimesylate	RxReference drug
Vyvanse50MG · tablet, chewable;oral	Lisdexamfetamine Dimesylate	RxReference drug
Vyvanse60MG · tablet, chewable;oral	Lisdexamfetamine Dimesylate	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Apr 23, 2026	Supplement 9Labeling · Standard review	Approved	Letter Label Medication Guide
Sep 23, 2025	Supplement 11Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 13, 2023	Supplement 7Labeling · Standard review	Approved	Label Letter
Feb 25, 2022	Supplement 5Labeling	Approved	Label Letter
Nov 2, 2021	Supplement 4Labeling · Standard review	Approved	Letter Label
Jul 29, 2021	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 31, 2017	Supplement 2Labeling · Standard review	Approved	Letter Label
May 19, 2017	Supplement 1Labeling	Approved	Label Letter
Jan 28, 2017	Original applicationNew dosage form · Standard review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 208510
Drugs@FDA: Overview at FDA
Company: Takeda Pharmaceuticals USA

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