Q. I was delighted to read about FDA concerns regarding generic Concerta. My prescription insurance is going to an essentially generic-only pricing system that will push the price of brand-name Concerta up hundreds of dollars a month for us starting in January.
I was planning to do anything possible to keep my son on Concerta, since it is the only thing that helps him stay focused on his studies in high school.
I didn’t know how I could fight the change to generic since it became available last year. Having the FDA make this announcement should help us.
A. The FDA recently noted that two generic formulations of Concerta (methylphenidate ER) might not work as well as the brand name medicine. The manufacturers are Mallinckrodt and Kudco.
According to the FDA,
“Janssen also manufactures an authorized Concerta generic, which is marketed by Actavis under a licensing agreement and is identical to Janssen’s Concerta.”
This authorized generic might resolve your dilemma.
If you would like to read more about why this is such a big deal, check out our recent article: “FDA Drops a Bombshell on Slow-Release Generic Drugs.”
This is really important because it reveals some well-kept secrets about the FDA drug approval process, especially with regard to slow-release (aka, long acting or LA, extended release or ER, etc) drugs.
