New Generic for Concerta
Oct. 21, 2016 - The US FDA approved an AB-rated (therapeutically equivalent) generic for Concerta (methylphenidate). Its AB rating means that the new generic is interchangeable with Concerta, which is manufactured by Janssen. This approval comes shortly after the FDA announced that it was initiating actions to revoke approval for two extended-release methylphenidate products that are rated BX (presumed therapeutically inequivalent) to Concerta. Mylan, the manufacturer of the new generic for Concerta has not yet released any launch or pricing details. Actavis distributes an authorized generic, which will remain on the market.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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.