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FDA Approves Adhansia XR for ADHD

Adlon Therapeutics news release; 2019 Mar 1

Adlon Therapeutics LP, a subsidiary of Purdue Pharma LP, has announced that the US Food and Drug Administration (FDA) approved Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII, a central nervous system (CNS) stimulant, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged ≥6 years. In the US, Purdue Pharma LP is headquartered in Stamford, CT.

Dosage and administration: Recommended starting dose for patients ≥6 years is 25 mg once daily in the morning. Dosage may be increased in increments of 10 to 15 mg at intervals of at least 5 days. The capsules can be administered with or without food. Capsules may be swallowed whole or opened and the entire contents sprinkled onto a tablespoon of applesauce or yogurt. If sprinkled, the contents should be taken without crushing or chewing.

Adverse reactions: The most common (≥5% and twice the rate of placebo) adverse reactions

occurring with Adhansia XR in pediatric patients are decreased appetite, insomnia, and weight decrease.

Citation:

Adlon Therapeutics L.P. announces FDA approval for Adhansia XR (methylphenidate HCl) extended-release capsules CII for the treatment of ADHD. [news release]. Stamford, CT: Purdue Pharma LP. March 1, 2019. http://www.adlontherapeutics.com/fda-approval-adhansia.html. Accessed March 8, 2019.