| Active Ingredient | LISDEXAMFETAMINE DIMESYLATE (TABLET, CHEWABLE) |
|---|
| Drug Name | FDA Application No. | Company | Dosage Form;Route | Strength | RLD Strength | Original Approval or Tentative Approval Date |
Exclusivity Expiration (NCE) |
Exclusivity Expiration (ODE) |
Chemical Type |
Review Classification |
Marketing Status |
TE Code |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| VYVANSE | NDA 208510 | SHIRE DEV LLC | TABLET, CHEWABLE;ORAL | 10 MG, 20 MG, 30 MG, 40 MG, 50 MG, 60 MG | 60 MG | January 28, 2017 | _ | _ | Type 3 - New Dosage Form | STANDARD | Prescription | None |
| Parameters | Details |
|---|---|
| Structural Formula |
/Structural_Formula.jpg) |
| Chemical Name | (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl]hexanamide dimethanesulfonate |
| CAS No | 608137-32-2 |
| Molecular Formula | C15H25N3O•(CH4O3S)2 |
| Molecular Weight | 455.6 |
| Appearance | White to off-white powder |
| Solubility | - |
| Water Solubility | Soluble in water (792 mg/mL) |
| Polymorphism | - |
| pKa (Strongest Acidic) | 15.89 (Predicted) |
| pKa (Strongest Basic) | 10.21 (Predicted) |
| Log P | 1.06 (Predicted) |
| Identification | - |
| Degradation | - |
| Hygroscopic | - |
| Photostability study | - |
| Melting Point | - |
| BCS Class | I |
| Manufacture of API | - |
| Parameters | Details |
|---|---|
| Indications and Usage | VYVANSE is a central nervous system (CNS) stimulant indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) Moderate to Severe Binge Eating Disorder (BED) in adults Limitation of Use: VYVANSE is not indicated for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of VYVANSE for the treatment of obesity have not been established |
| Dosage and Administration |
Severe renal impairment: Maximum dose is 50 mg/day End stage renal disease (ESRD): Maximum dose is 30 mg/day Refer Label for fr details |
| Mechanism of action | Lisdexamfetamine is a prodrug of dextroamphetamine. Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD and BED is not known. |
| Absorption |
After a single dose administration of 60 mg VYVANSE chewable tablet in healthy subjects under fasted conditions, Tmax of lisdexamfetamine and dextroamphetamine was reached at approximately 1 hour and 4.4 hour post dose, respectively. Compared to 60 mg VYVANSE capsule, exposure (Cmax and AUC) to lisdexamfetamine was about 15% lower. The exposure (Cmax and AUCinf ) of dextroamphetamine is similar between VYVANSE chewable tablet and VYVANSE capsule. |
| Food Effect | Administration of 60 mg VYVANSE chewable tablet with food (a high-fat meal) decreases the exposure (Cmax and AUCinf) of dextroamphetamine by about 5% to 7%, and prolongs mean Tmax by approximately 1 hour (from 3.9 hrs at fasted state to 4.9 hours). |
| Distribution | - |
| Metabolism | Lisdexamfetamine is converted to dextroamphetamine and l-lysine primarily in blood due to the hydrolytic activity of red blood cells after oral administration of lisdexamfetamine dimesylate. In vitro data demonstrated that red blood cells have a high capacity for metabolism of lisdexamfetamine; substantial hydrolysis occurred even at low hematocrit levels (33% of normal). Lisdexamfetamine is not metabolized by cytochrome P450 enzymes. |
| Elimination |
Plasma concentrations of unconverted lisdexamfetamine are low and transient, generally becoming non-quantifiable by 8 hours after administration. The plasma elimination half-life of lisdexamfetamine typically averaged less than one hour in studies of lisdexamfetamine dimesylate in volunteers. The mean plasma elimination half- life of dextroamphetamine was about 12 hours after oral administration of lisdexamfetamine dimesylate. Following oral administration of a 70 mg dose of radiolabeled lisdexamfetamine dimesylate to 6 healthy subjects, approximately 96% of the oral dose radioactivity was recovered in the urine and only 0.3% recovered in the feces over a period of 120 hours. Of the radioactivity recovered in the urine, 42% of the dose was related to amphetamine, 25% to hippuric acid, and 2% to intact lisdexamfetamine. |
| Peak plasma time (Tmax) | 1 hour and 4.4 hour |
| Half life | Less than one hour |
| Bioavailability | - |
| Age, gender | - |
| DMF | Status | Type | Submit Date | Holder |
|---|---|---|---|---|
| 22442 | A | II | January 27, 2009 | JOHNSON MATTHEY INC PHARMACEUTICAL MATERIALS GROUP |
| Parameters | Details | ||||||
|---|---|---|---|---|---|---|---|
| Strength | 10 mg | 20 MG | 30 MG | 40 MG | 50 MG | 60 MG | |
| Excipients used | Colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate, mannitol, microcrystalline cellulose, sucralose, artificial strawberry flavor. | ||||||
| Composition of coating material | - | ||||||
| Composition of caspule shell | - | ||||||
| Pharmaceutical Development | VYVANSE chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7mg of lisdexamfetamine). | ||||||
| Manufacture of the product | - | ||||||
| Tablet / Capsule Image | |||||||
| Appearance | White to off-white round shaped tablet debossed with ‘10’ on one side and ‘S489’ on the other | White to off-white hexagonal shaped tablet debossed with ‘20’ on one side and ‘S489’ on the other | White to off-white arc triangular shaped tablet debossed with ‘30’ on one side and ‘S489’ on the other | White to off-white capsule shaped tablet debossed with ‘40’ on one side and ‘S489’ on the other | White to off-white arc square shaped tablet debossed with ‘50’ on one side and ‘S489’ on the other | White to off-white arc diamond shaped tablet debossed with ‘60’ on one side and ‘S489’ on the other | |
| Imprint code / Engraving / Debossment | Debossed with ‘10’ on one side and ‘S489’ on the other | Debossed with ‘20’ on one side and ‘S489’ on the other | Debossed with ‘30’ on one side and ‘S489’ on the other | Debossed with ‘40’ on one side and ‘S489’ on the other | Debossed with ‘50’ on one side and ‘S489’ on the other | Debossed with ‘60’ on one side and ‘S489’ on the other | |
| Score | No score | No score | No score | No score | No score | No score | |
| Color | White to off-white | White to off-white | White to off-white | White to off-white | White to off-white | White to off-white | |
| Shape | Round | Hexagonal | Arc triangular | Capsule | Arc square | Arc diamond | |
| Dimension | 16 mm | 16 mm | 16 mm | 16 mm | 16 mm | 16 mm | |
| Mfg by | - | ||||||
| Mfg for | Shire US Inc. (Made in US) | ||||||
| Marketed by | - | ||||||
| Distributed by | - | ||||||
| Application No. | Prod No | Patent No | Patent Expiration | Drug Substance Claim | Drug Product Claim | Patent Use Code | Delist Requested | Link |
|---|---|---|---|---|---|---|---|---|
| N208510 | 1 | 7105486 | February 24, 2023 | - | - | U-727 | - | Download |
| N208510 | 1 | 7223735 | February 24, 2023 | - | DP | - | - | Download |
| N208510 | 1 | 7655630 | February 24, 2023 | DS | DP | - | - | Download |
| N208510 | 1 | 7659253 | February 24, 2023 | DS | DP | U-727 | - | Download |
| N208510 | 1 | 7659254 | February 24, 2023 | - | - | U-727 | - | Download |
| N208510 | 1 | 7662787 | February 24, 2023 | DS | - | - | - | Download |
| N208510 | 1 | 7662788 | February 24, 2023 | - | - | U-727 | - | Download |
| N208510 | 1 | 7671030 | February 24, 2023 | - | DP | U-727 | - | Download |
| N208510 | 1 | 7671031 | February 24, 2023 | - | - | U-727 | - | Download |
| N208510 | 1 | 7674774 | February 24, 2023 | - | DP | U-727 | - | Download |
| N208510 | 1 | 7678770 | February 24, 2023 | - | - | U-727 | - | Download |
| N208510 | 1 | 7678771 | February 24, 2023 | - | DP | U-727 | - | Download |
| N208510 | 1 | 7687466 | February 24, 2023 | - | DP | - | - | Download |
| N208510 | 1 | 7687467 | February 24, 2023 | - | DP | U-727 | - | Download |
| N208510 | 1 | 7713936 | February 24, 2023 | - | - | U-727 | - | Download |
| N208510 | 1 | 7718619 | February 24, 2023 | - | DP | U-727 | - | Download |
| N208510 | 1 | 7723305 | February 24, 2023 | - | DP | U-727 | - | Download |
| USP Apparatus | Speed (RPMs) | Medium | Volume (mL) | Recommended Sampling Times (minutes) | Date Updated |
|---|---|---|---|---|---|
| Not Available | |||||
| Label | Link |
|---|---|
| FDA label | Download |
| FDA chemistry review | Download |
| FDA Pharmacology Review(s) | |
| FDA Clinical Pharmacology Biopharmaceutics Review(s) | Download |
| FDA BE Recommendation | |
| European Public Assessment Report |
| - |
| www.accessdata.fda.gov, www.drugbank.ca, www.ema.europa.eu, www.medicines.org.uk, dailymed.nlm.nih.gov |
