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FDA Approves ADHD Drug for Patients 6 and Older

Neos Therapeutics news release; 2017 Sep 15

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.

Dosage/administration:

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.

Adverse reactions:

  • 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.

Citation:

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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