Mydayis Approved for Treatment of ADHD
June 20, 2017 – The U.S. FDA has approved Mydayis™ (mixed salts of single-entity amphetamine product, CII) capsules, manufactured by Shire. Mydayis is approved for the treatment of attention deficit hyperactive disorder (ADHD) in patients 13 years of age and older. The recommended starting dose is 12.5mg once daily. If needed, this dose can be titrated by 12.5mg per week to a maximum daily dose of 25mg in children (13 to 17 years) and 50mg per day for adults. Mydayis has a duration of action up to 16 hours, and is a follow-on to the company’s Adderall XR® (mixed salts of single-entity amphetamine product, CII), which lasts for up to 12 hours. Shire plans to launch Mydayis as 12.5mg, 25mg, 37.5mg and 50mg extended-releases capsules during the third quarter of 2017.
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.