lisdexamfetamine dimesylate
Drug Details
- Generic Name
- lisdexamfetamine dimesylate
- Brand Names
- Vyvanse, lisdexamfetamine dimesylate, LISDEXAMFETAMINE DIMESYLATE, Lisdexamfetamine Dimesylate
- Application Number
- NDA021977
- Sponsor
- Takeda Pharmaceuticals America, Inc.
- NDC Codes
- 46
- Dosage Forms
- CAPSULE, TABLET, CHEWABLE
- Routes
- ORAL
- Active Ingredients
- LISDEXAMFETAMINE DIMESYLATE
Indications and Usage
1 INDICATIONS AND USAGE Lisdexamfetamine dimesylate capsules are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1 )] Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2 )] . Limitations of Use: Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see Use in Specific Populations ( 8.4 )] . Lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see Warnings and Precautions ( 5.2 )] . Lisdexamfetamine dimesylate capsules are a central nervous system (CNS) stimulant indicated for the treatment of ( 1 ): Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older Moderate to severe binge eating disorder (BED) in adults Limitations of Use: Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older ( 8.4 ) Lisdexamfetamine dimesylate capsules are 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 lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established ( 5.2 )