Neos Therapeutics, Inc., has announced that the US Food and Drug Administration (FDA) has approved Adzenys ER (amphetamine) extended-release oral suspension for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged ≥6 years. Neos Therapeutics is headquartered in Dallas and Fort Worth, Texas.
Indications: Adzenys ER is a central nervous system (CNS) stimulant indicated for the treatment of ADHD) in patients aged ≥6 years.
Pediatric patients (aged 6 to 17 years):
- Starting dose is 6.3 mg (5 mL) once daily in the morning.
- Maximum dose is 18.8 mg (15 mL) for patients 6 to 12 years, and 12.5 mg (10 mL) once daily for patients 13 to 17 years.
Adults: 12.5 mg (10 mL) once daily in the morning.
- Pediatric patients aged 6 to 12 years: Most common adverse reactions were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever.
- Pediatric patients aged 13 to 17 years: Adverse reactions included loss of appetite, insomnia, abdominal pain, weight loss, and nervousness.
- Adults: Adverse reactions included dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, and urinary tract infections.
Neos Therapeutics receives US FDA approval of Adzenys ER (amphetamine) extended-release oral suspension for the treatment of ADHD in patients 6 years and older. [news release]. Dallas and Fort Worth, TX: Neos Therapeutics, Inc. September 15, 2017. https://globenewswire.com/news-release/2017/09/15/1123438/0/en/Neos-Therapeutics-Receives-U-S-FDA-Approval-of-Adzenys-ER-amphetamine-Extended-Release-Oral-Suspension-for-the-Treatment-of-ADHD-in-Patients-6-Years-and-Older.html. Accessed September 25, 2017.
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FDA Approves ADHD Drug for Patients 6 and Older, Neos Therapeutics news release; 2017 Sep 15