FDA Reclassifies Some Generic Extended-Release Methylphenidate
November 14, 2014 – FDA has changed the interchangeability classification for generic extended-release methylphenidate, made by Kudco Ireland Ltd and Mallinckrodt. Methylphenidate is indicated to treat attention-deficit hyperactivity disorder (ADHD) and narcolepsy. Originally approved as AB-rated (therapeutically equivalent) to Janssen’s Concerta®, the affected methylphenidate products were reclassified to BX (presumed therapeutically inequivalent) as of November 13, 2014. Although safety issues were not found and the reclassified products can still be prescribed and dispensed, they cannot be interchanged automatically with Concerta.
The generic companies have six months to provide the FDA with evidence that their products are equivalent to Concerta or they will be required to withdraw the generics from sale in the U.S. The generics from Kudco and Mallinckrodt were not the only FDA-approved generics to Concerta. Actavis continues to market an authorized generic to the product.
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. Prices referenced are estimates based on available data and are subject to change at the time a claim is processed. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information purposes only. The reference to any medication above does not imply that the medication is covered by your plan.