FDA questions effectiveness of two generic versions of Concerta

FDA recently raised concerns that two generic versions of Concerta (methylphenidate hydrochloride extended-release tablets; Janssen Pharmaceuticals) may not be therapeutically equivalent to the brand-name drug.

FDA said its concerns are based on an analysis of data. The two generic versions of Concerta are manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd. Concerta is used to treat attention-deficit hyperactivity disorder in adults and children.

FDA said it has not identified any serious safety concerns with the two generics and that patients using the two products should not make changes without consulting healthcare professionals.

“If you, or those under your care, are taking the Mallinckrodt or Kudco products and have concerns about lack of desired effect during the dosing period, contact the prescribing healthcare provider to discuss whether or not a different drug product would be more appropriate,” the FDA wrote.

According to FDA, the generic versions of Concerta manufactured by Mallinckrodt and Kudco have raised concerns that the products may not produce the same therapeutic benefits for some patients as would the brand-name product. Methylphenidate hydrochloride extended-release products are intended to release the drug in the body over a period of 10 to 12 hours. This should allow for a single-dose product that is consistent with the effect of a three-times-per-day dose of immediate-release methylphenidate hydrochloride.

In some individuals, FDA said, the Mallinckrodt and Kudco products may release drug in the body at a slower rate during the 7- to 12-hour range. The diminished release rate may result in patients not receiving the desired effect.


FDA has changed the therapeutic equivalence rating for the Mallinckrodt and Kudco products from AB to BX, which means they will no longer be recommended as automatic substitutes for Concerta. Mallinckrodt and Kudco have been given six months either to confirm the bioequivalence of their products, using revised bioequivalence standards, or to voluntarily withdraw their products from the market.