Rose
The FDA was aware of concerns about the bio equivalence of generic Concerta in early 2013 and IDENTIFIED IT AS A PRIORITY. At the end of 2017 the decided they would make a decision to ask politely for the generics to withdraw voluntarily their products.
“While the withdrawal proceedings are ongoing, the Mallinckrodt and Kremers products are still approved and can be prescribed”
“The FDA and stakeholders have identified the study of generic methylphenidate hydrochloride ER tablets as a priority. Under the Generic Drug User Fee Amendments of 2012 regulatory science initiative, the FDA commissioned two studies: a bioequivalence study in healthy adult volunteers examining the Mallinckrodt product, which started in October 2014 and has been completed, and a pharmacokinetic and pharmacodynamic study in children with ADHD, which started in October 2014 and is expected to finish by September 2017. In the completed bioequivalence study, it was found that the Mallinckrodt product did not satisfy the bioequivalence criteria with respect to Concerta.”
Generics have several years to sell and make hundreds of millions before they are asked to voluntarily remove their product from the market.
Concerta was a “priority”, a preventative therapeutic with no detectable adverse effects will not be a priority.
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