Generic Strattera Launched
May 31, 2017 – The U.S. Food and Drug Administration (FDA) has approved the first AB-rated generics to Lilly’s Strattera® (atomoxetine), a drug approved for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Generic exclusivity was not granted. Generics were approved from Apotex, Aurobindo, Glenmark and Teva.
Strattera is a non-stimulant drug originally approved by the FDA in 2002. The last patent for Strattera expired on May 26, 2017. As a result, the FDA was able to approve all eligible atomoxetine abbreviated new drug applications (ANDAs).
Shipments of the generics have already begun.
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 1800-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.