Amphetamine Extended-Release
Drug Details
- Generic Name
- Amphetamine Extended-Release
- Brand Names
- Amphetamine Extended-Release
- Application Number
- NDA204326
- Sponsor
- Neos Therapeutics, LP
- NDC Codes
- 6
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING
- Routes
- ORAL
- Active Ingredients
- AMPHETAMINE
Indications and Usage
1 INDICATIONS AND USAGE Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies ( 14 )]. Limitations of Use The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5). Use in Specific Populations (8.4) ]. Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. ( 1 ) Limitations of Use The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.5, 8.4)