FDA has issued a statement re generic versions of Concerta

[hsmom]

FDA has received numerous complaints about generic versions of Concerta made by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd. and has given both companies six months to demonstrate their products’ bioequivalency to Concerta.


www.fda.gov/Drugs/DrugSafety/ucm422568.htm

[healthy11]

Thank you for posting this!! Although my son uses a different ADHD medication, I'm thrilled to hear that the FDA is concerned about the fact that some "generics" don't equate to the "brand name" products in daily usage situations. While small-scale lab results might claim they're equivalent, it's "real life" circumstances that actually matter. I'm sure generic Concerta isn't the only product that they should investigate.

[Mayleng]

Yup, there are a lot of generics that should be investigated. I know my son had different reactions to different brand of generics too when he was using ritalin. I find that I will now only use name brand for him.

[michellea]

I am very glad to hear of this. There is one generic Concerta that is exactly the same as the brand name - Watson/Actavis. They entered "into an agreement with Concerta’s manufacturer, Janssen: Watson would delay introducing their own generic to compete with Concerta if Janssen would manufacture and supply Watson with this brand-name Concerta, allowing it to market at a cheaper-than-brand price and give Janssen a piece of the profits." adhdrollercoaster.org/the-basics/an-update-on-generic-concerta/#.VG-GMygsY9Y This "generic" uses the exact formulation plus the OROS, the laser-drilled osmotic pump that is the Concerta delivery-system technology. The other manufacturers do not use the same delivery system (which is what makes concerta, concerta) and could have slightly different formulations of the active and inactive ingredients themselves.

My son's neurologist writes that if a generic is to be given, it should only be from Watson with ALZA logo imprinted on the capsule. I had to call around to many pharmacies to find one that carries the Watson version and I ultimately switched from CVS to Walgreens. I found that Target, Costco and Rite Aide did not have the Watson version either. My sense is that Watson, while generic, is more expensive than the others.

It is beyond me how the generics covered by this study could ever get away with calling themselves Concerta generics. I am glad that the complaints have been heard.

[LurkNoMore]

Last year (Fall of 2013) our pharmacy switched to the generic Concerta. We tried to different generics from 2 different pharmacies, Mallinckrodt from RiteAid and Kremer Urban from CVS. After that, we had to have his pdoc fill out a form with our insurance company so they would cover the brand name Concerta - now I just make sure the pdoc writes DAW on the prescription...and the pharmacy usually has to order it.

[LurkNoMore]

We had our pdoc fill out the paperwork for the insurance company again - C is approved to get Concerta for another year (we pay $40 for the concerta instead of $5 for generics & $20 for brand names taht are on the formulary).