Posted from: Monday, October 31, 2016 - 03:46 PM - Present

Generics for Concerta

FDA has begun proceedings to rescind its approvals for two generics of Janssen’s Concerta® (methylphenidate) extended-release tablets, following up on previous actions. In November 2014, FDA amended its Draft Guidance on Methylphenidate Hydrochloride to revise the methods for determining bioequivalence (interchangeability) of methylphenidate products. At that time, FDA notified the manufacturers of the two generics available in the U.S. that the bioequivalence ratings of their products changed from AB-rated (therapeutically equivalent) to BX (presumed therapeutically inequivalent) under the new guidance. No safety issues were found with either generic, so they still can be prescribed and dispensed. However, they cannot be interchanged automatically with Concerta. Both companies, Mallinckrodt and Kudco, had the options of removing their generic product from the U.S. market or carrying out bioequivalency studies to show therapeutic effects comparable to those of Concerta. Kudco subsequently was sold to UCB/Kremers Urban, which then was bought by Lannett in 2015. Neither Lannett nor Mallinckrodt has complied with the FDA directive, so both have been given 30 days to request a hearing. If a hearing is granted, an additional 30 days is allowed for all information needed to prove the generic is bioequivalent. If they do not respond or fail to support bioequivalence, FDA will withdraw approval and the products will no longer be available in the U.S. An authorized generic made by Janssen will continue to be distributed under the Actavis label.


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.

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.


Last Updated Friday, October 18, 2019 - 01:54 AM.