FDA Questions Effectiveness of Two Generic Versions of Concerta

Two generic versions of methylphenidate hydrochloride extended-release tablets, the generic form of Concerta® used to treat attention-deficit disorder and attention-deficit hyperactivity disorder in adults and children may not work as effectively as the brand-name product according to a recent report released by the U.S Food and Drug Administration (FDA). After an investigation into adverse event reports submitted by physicians and patients and data previously provided by the manufacturers and independent FDA lab tests, the FDA concluded the generic products made by Mallinckrodt and Kudco, which are intended to be released in the body over a 10 to 12 hour period, were actually delivering the medication at a slower rate, closer to the 7 to 12 hour rate. This slower release rate means the drug may be less effective.


As a result of these findings the FDA has reclassified the therapeutic equivalence rating for the generic products manufactured by Mallinckrodt and Kudco from an AB rating to a BX rating. This means pharmacists can no longer automatically substitute these generics if a prescriber writes a prescription for brand-name Concerta. The generic version of Concerta manufactured by Actavis was found to be bioequivalent and is still classified as an AB rated generic.


There are no current safety concerns associated with these two generic versions of Concerta and patients should not make changes in their medication regimen before speaking with their doctor. The FDA has given Mallinckrodt and Kudco six months to confirm the effectiveness of their products or withdraw from the market.


Reference
FDA.gov. Melthylphenidate Hydrochloride Extended Release Tablets (generic Concerta) made by Mallinckrodt and Kudco.

http://www.fda.gov/Drugs/DrugSafety/ucm422568.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed November 19, 2014.

FDA Questions Effectiveness of Two Generic Versions of Concerta

Two generic versions of methylphenidate hydrochloride extended-release tablets, the generic form of Concerta® used to treat attention-deficit disorder and attention-deficit hyperactivity disorder in adults and children may not work as effectively as the brand-name product according to a recent report released by the U.S Food and Drug Administration (FDA). After an investigation into adverse event reports submitted by physicians and patients and data previously provided by the manufacturers and independent FDA lab tests, the FDA concluded the generic products made by Mallinckrodt and Kudco, which are intended to be released in the body over a 10 to 12 hour period, were actually delivering the medication at a slower rate, closer to the 7 to 12 hour rate. This slower release rate means the drug may be less effective.


As a result of these findings the FDA has reclassified the therapeutic equivalence rating for the generic products manufactured by Mallinckrodt and Kudco from an AB rating to a BX rating. This means pharmacists can no longer automatically substitute these generics if a prescriber writes a prescription for brand-name Concerta. The generic version of Concerta manufactured by Actavis was found to be bioequivalent and is still classified as an AB rated generic.


There are no current safety concerns associated with these two generic versions of Concerta and patients should not make changes in their medication regimen before speaking with their doctor. The FDA has given Mallinckrodt and Kudco six months to confirm the effectiveness of their products or withdraw from the market.


Reference
FDA.gov. Melthylphenidate Hydrochloride Extended Release Tablets (generic Concerta) made by Mallinckrodt and Kudco.

http://www.fda.gov/Drugs/DrugSafety/ucm422568.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed November 19, 2014.

Bookmark this site
Copyright 2014 by WellDyneRx