FDA Turns Attention To Generic Concerta...

(RTTNews) - The FDA has expressed concern that generic versions of attention deficit hyperactive disorder drug Concerta, manufactured by Mallinckrodt plc (MNK) and Kudco Ireland Ltd., may not produce the same therapeutic benefits for some patients as the brand-name drug.

The branded drug, Concerta, for the treatment of attention deficit hyperactive disorder in children, adolescents, and adults, was first approved by FDA in August 2000, and is manufactured by Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson (JNJ).

Mallinckrodt's generic Concerta, of strengths 27-, 36-, and 54-milligram, was approved by FDA in December 2012 while Kudco's generic version of the drug of 18- and 27-milligram strengths received approval last July and 36- and 54-milligram strengths received approval last September.

Concerta uses the unique OROS (Osmotic Release Oral System) delivery system to deliver methylphenidate HCl at a controlled rate while the generic versions use a different delivery system. Mallinckrodt's generic version uses diffusion process and Kudco's generic version uses bead technology to deliver the medication.

An authorized generic for Concerta is also available, which is manufactured by Janssen and marketed by Actavis under a licensing agreement. The authorized generic uses OROS, the same delivery-system technology as that of the branded drug Concerta.

There have been complaints of lack of therapeutic effect associated with the generic versions of Concerta, manufactured by Mallinckrodt and Kudco, ever since they were approved. Based on an analysis of data, the FDA has now concluded that the two regular generics for Concerta may not be therapeutically equivalent to the brand-name drug.

As a result, the therapeutic equivalence (TE) rating for the Mallinckrodt and Kudco products has been changed from AB to BX. This means the Mallinckrodt and Kudco products are still approved and can be prescribed, but are no longer recommended as automatically substitutable at the pharmacy (or by a pharmacist) for Concerta, the FDA noted.

The draft guidance for industry for bioequivalence testing for Concerta has also been revised by the FDA. Mallinckrodt and Kudco are required to confirm the bioequivalence of their products using the revised bioequivalence standards within six months, failing which the products will have to be taken off the market.