Adzenys ER Approved for ADHD
September 15, 2017 – The U.S. FDA has approved Adzenys ER™ (amphetamine) extended-release oral suspension, manufactured by Neos Therapeutics, for treatment of attention deficit hyperactivity disorder (ADHD) in children six years and older. The drug is considered a bioequivalent of Adderall XR® (mixed salts of a single-entity amphetamine) capsules, and therefore is interchangeable with Adderall XR.
Recommended dosing for Adzenys ER is once per day, in the morning, with dosage amounts based on the age of the patient. Adzenys ER will be available in 450mL bottles at a concentration of 1.25mg of amphetamine per milliliter. The drug carries a black box warning cautioning that it may be subject to misuse and can cause dependence, as it is a C-II controlled substance. A medication guide is provided with every prescription fill and refill of Adzenys ER. Launch is planned for early 2018.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.