Serdexmethylphenidate and Dexmethylphenidate

FDA Drug Profile — AZSTARYS

Drug Details

Generic Name
Serdexmethylphenidate and Dexmethylphenidate
Brand Names
AZSTARYS
Application Number
NDA212994
Sponsor
Corium, LLC.
NDC Codes
3
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
DEXMETHYLPHENIDATE HYDROCHLORIDE, SERDEXMETHYLPHENIDATE CHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Limitations of Use The use of AZSTARYS 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 ( 5.7 ), Use in Specific Populations ( 8.4 )]. AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. ( 1 ) Limitations of Use The use of AZSTARYS 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 (5.7, 8.4).