FDA-Approved Biosimilar Medications for Adult ADHD Management

July. 16,2025

This article highlights FDA-approved biosimilar medications for adult ADHD, including key drugs like Strattera, Mydayis, and Cotempla XR-ODT. It emphasizes the importance of diagnosis and professional consultation before starting treatment. The content offers insights into how these medications function and their approval status, providing valuable information for patients and healthcare providers. Understanding these options can help manage adult ADHD effectively and safely.

FDA-Approved Biosimilar Medications for Adult ADHD Management

Attention Deficit Hyperactivity Disorder (ADHD) impacts brain development and daily functioning across all age groups. While commonly recognized in children, untreated symptoms can persist into adulthood, often worsening over time. Recently, the FDA has approved several biosimilar drugs specifically for treating adult ADHD, addressing the severity of symptoms in adults.

Importance of Proper Diagnosis

Symptoms in children—such as difficulty focusing, controlling impulses, or hyperactivity—are sometimes overlooked. Persistent symptoms require professional diagnosis to confirm ADHD, ensuring timely treatment.

  • The FDA has approved generic Strattera (atomoxetine) for both children and adults with ADHD.

Manufacturers produce this medication in various strengths. It is important to follow usage instructions and warnings provided with the medication.

  • Shire’s Mydayis (SHP465), approved by the FDA for those aged 12 and above, combines amphetamine and dextroamphetamine to effectively manage hyperactivity and impulsivity for up to 16 hours.
  • Cotempla XR-ODT, approved for children aged 6 to 17, is the first orally disintegrating tablet that dissolves quickly in the mouth, offering convenience without water or chewing.

These medications work gradually, so consulting a healthcare professional before use is essential for safe treatment of adult ADHD.