Regulatory PathRegulatory requirements compared

Active substance

Lisdexamfetamine

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
VYVANSE30MG; 50MG; 70MG; 20MG; 40MG; 60MG; 10MGcapsule · oralTAKEDA PHARMS USAPrescription23 Feb 2007
VYVANSE10MG; 20MG; 30MG; 40MG; 50MG; 60MGtablet, chewable · oralTAKEDA PHARMS USAPrescription28 Jan 2017
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralACTAVIS ELIZABETHPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE20MG; 30MG; 40MG; 50MG; 60MG; 70MG; 10MGcapsule · oralHIKMA PHARMSPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralAMNEALPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralMYLANPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralSPECGX LLCPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MGtablet, chewable · oralSUN PHARM INDS INCPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralSUN PHARM INDS INCPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralNORWICHPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralRHODES PHARMSPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MGtablet, chewable · oralTEVA PHARMSPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralLANNETT CO INCPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralPRINSTON INCPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralAPOTEXPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MGtablet, chewable · oralASCENT PHARMS INCPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralALKEM LABS LTDPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralASCENT PHARMS INCPrescription25 Aug 2023
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MGtablet, chewable · oralMSNPrescription2 Feb 2024
LISDEXAMFETAMINE DIMESYLATE20MG; 30MG; 40MG; 50MG; 60MG; 70MG; 10MGcapsule · oralSANDOZPrescription26 Jul 2024
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralELITE LABS INCPrescription15 Nov 2024
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MGtablet, chewable · oralGRANULESPrescription16 Dec 2024
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MGtablet, chewable · oralSPECGX LLCPrescription17 Dec 2024
LISDEXAMFETAMINE DIMESYLATE10MG; 20MG; 30MG; 40MG; 50MG; 60MG; 70MGcapsule · oralGRANULESPrescription29 Jan 2025
ARYNTA10MG/MLsolution · oralAZURITYPrescription16 Jun 2025

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AG-LISDEXAMFETAMINE0253756710 MGCAPSULE · ORALANGITA PHARMA INC.
AG-LISDEXAMFETAMINE0253757520 MGCAPSULE · ORALANGITA PHARMA INC.
AG-LISDEXAMFETAMINE0253758330 MGCAPSULE · ORALANGITA PHARMA INC.
AG-LISDEXAMFETAMINE0253759140 MGCAPSULE · ORALANGITA PHARMA INC.
AG-LISDEXAMFETAMINE0253760550 MGCAPSULE · ORALANGITA PHARMA INC.
AG-LISDEXAMFETAMINE0253761360 MGCAPSULE · ORALANGITA PHARMA INC.
APO-LISDEXAMFETAMINE CAPSULES0254664710 MGCAPSULE · ORALAPOTEX INC
APO-LISDEXAMFETAMINE CAPSULES0254665520 MGCAPSULE · ORALAPOTEX INC
APO-LISDEXAMFETAMINE CAPSULES0254666330 MGCAPSULE · ORALAPOTEX INC
APO-LISDEXAMFETAMINE CAPSULES0254667140 MGCAPSULE · ORALAPOTEX INC
APO-LISDEXAMFETAMINE CAPSULES0254669850 MGCAPSULE · ORALAPOTEX INC
APO-LISDEXAMFETAMINE CAPSULES0254670160 MGCAPSULE · ORALAPOTEX INC
APO-LISDEXAMFETAMINE CAPSULES0254672870 MGCAPSULE · ORALAPOTEX INC
APO-LISDEXAMFETAMINE CHEWABLE TABLETS0253444410 MGTABLET (CHEWABLE) · ORALAPOTEX INC
APO-LISDEXAMFETAMINE CHEWABLE TABLETS0253445220 MGTABLET (CHEWABLE) · ORALAPOTEX INC
APO-LISDEXAMFETAMINE CHEWABLE TABLETS0253446030 MGTABLET (CHEWABLE) · ORALAPOTEX INC
APO-LISDEXAMFETAMINE CHEWABLE TABLETS0253447940 MGTABLET (CHEWABLE) · ORALAPOTEX INC
APO-LISDEXAMFETAMINE CHEWABLE TABLETS0253448750 MGTABLET (CHEWABLE) · ORALAPOTEX INC
APO-LISDEXAMFETAMINE CHEWABLE TABLETS0253449560 MGTABLET (CHEWABLE) · ORALAPOTEX INC
JAMP LISDEXAMFETAMINE0253512210 MGCAPSULE · ORALJAMP PHARMA CORPORATION
JAMP LISDEXAMFETAMINE0253513020 MGCAPSULE · ORALJAMP PHARMA CORPORATION
JAMP LISDEXAMFETAMINE0253514930 MGCAPSULE · ORALJAMP PHARMA CORPORATION
JAMP LISDEXAMFETAMINE0253515740 MGCAPSULE · ORALJAMP PHARMA CORPORATION
JAMP LISDEXAMFETAMINE0253516550 MGCAPSULE · ORALJAMP PHARMA CORPORATION
JAMP LISDEXAMFETAMINE0253517360 MGCAPSULE · ORALJAMP PHARMA CORPORATION

41 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLISDEXAMFETAMINE 10 MG CAPSULE$2.624per EA23 Sep 2026
US NADACLISDEXAMFETAMINE 10 MG TB CHEW$3.73818per EA23 Sep 2026
US NADACLISDEXAMFETAMINE 20 MG CAPSULE$2.43711per EA23 Sep 2026
US NADACLISDEXAMFETAMINE 20 MG TB CHEW$4.33791per EA23 Sep 2026
US NADACLISDEXAMFETAMINE 30 MG CAPSULE$2.70088per EA23 Sep 2026
US NADACLISDEXAMFETAMINE 30 MG TB CHEW$3.29147per EA23 Sep 2026
US NADACLISDEXAMFETAMINE 40 MG CAPSULE$2.60126per EA23 Sep 2026
US NADACLISDEXAMFETAMINE 40 MG TB CHEW$3.98071per EA23 Sep 2026
US NADACLISDEXAMFETAMINE 50 MG CAPSULE$2.63983per EA23 Sep 2026
US NADACLISDEXAMFETAMINE 50 MG TB CHEW$3.64862per EA23 Sep 2026
US NADACLISDEXAMFETAMINE 60 MG CAPSULE$2.67291per EA23 Sep 2026
US NADACLISDEXAMFETAMINE 60 MG TB CHEW$3.64601per EA23 Sep 2026
NHS Drug TariffLisdexamfetamine 20mg capsules£54.6228 capsule1 Oct 2026
NHS Drug TariffLisdexamfetamine 30mg capsules£58.2428 capsule1 Oct 2026
NHS Drug TariffLisdexamfetamine 40mg capsules£62.8228 capsule1 Oct 2026
NHS Drug TariffLisdexamfetamine 50mg capsules£68.6028 capsule1 Oct 2026
NHS Drug TariffLisdexamfetamine 60mg capsules£75.1828 capsule1 Oct 2026
NHS Drug TariffLisdexamfetamine 70mg capsules£83.1628 capsule1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for lisdexamfetamine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.