The U.S. Food and Drug Administration (FDA) is proposing to issue a recall of two generic versions of to withdraw two generic versions of Concerta, the extended-release (ER) form of the attention-deficit hyperactive disorder (ADHD) drug methylphenidate hydrochloride. Back in 2014, the regulator already expressed doubts about the therapeutical equivalence (bioequivalence) between the brand-name drug manufactured by Janssen Pharmaceutical and the generic versions sold by Mallinckrodt Pharmaceuticals and UCB/Kremers Urban (formerly Kudco). Now, after a two-years evaluation period, the two companies still failed to provide reliable evidence that demonstrates that their products are sufficiently effective. Pharmacies cannot provide patients with their generic drugs instead of the branded one anymore.
According to data provided by the Center for Drug Evaluation and Research (CDER), the two generic capsules may release the active principle too slowly, causing the body to absorb it at a rate so reduced, it may yield no effect. For this reason, the FDA wants to downgrade the regulatory ratings for the two medicines. The two generic medications were originally approved in December 2012 and July 2013, after being submitted through the abbreviated new drug application (ANDA) process. When the CDER found that Mallinckrodt and Kremers Urban’s drug were not bioequivalent to Concerta, the two companies were asked to provide additional evidence which may prove the contrary. The data submitted by Kremers Urban Pharmaceuticals, however, was deemed insufficient by the FDA, and the company is now seeking a hearing in the near future to discuss its position. Mallinckrodt, instead, opted to file a lawsuit to prove the regulatory agency wrong. Although earlier this year a Maryland federal judge dismissed the claim, the manufacturer submitted another appeal this last Summer, together with some additional motions in the last few weeks.
Methylphenidate is a central nervous system stimulant drug used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children and adults, as well as narcolepsy. Concerta is the extended-release form of the other known drug Ritalin, and acts by increasing the levels of dopamine inside the brain enhancing patient’s attention, wakefulness and vigilance. Although methylphenidate has been used to treat ADHD and other conditions since the early 1980s, Concerta had been approved only in August 2000.
Article by Dr. Claudio Butticè, PharmD.
REFERENCES
- U.S. Food and Drug Administration (FDA). Methylphenidate Hydrochloride Extended Release Tablets (generic Concerta) made by Mallinckrodt and Kudco. www.fda.gov (Accessed November 2016)
- Ed Silverman (November 13, 2014). FDA Switches Key Classification for two Generic ADHD Pills. The Wall Street Journal
- CONCERTA® (methylphenidate HCl) Extended-release Tablets CII. Full prescribing information. (Accessed October 2016)