Cotempla XR-ODT Approved for Treatment of ADHD
June 19, 2017 – The U.S. FDA has approved once-daily Cotempla XR-ODT™ (methylphenidate) extended-release orally disintegrating tablets, manufactured by Neos Therapeutics. Cotempla XR-ODT is indicated to treat attention deficit hyperactive disorder (ADHD) in children and teens between 6 and 17 years of age. Launch is planned for the autumn of 2017 in blister-packages containing 8.6mg, 17.3mg or 25.9mg tablets. Because it is a C-II controlled substance, Cotempla XR-ODT has a medication guide for patients and a boxed warning about its possible abuse, misuse and/or dependence.
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.