A generic ADHD drug has been deemed unequal to Johnson & Johnson’s ADHD drug, Concerta, after the FDA tested it for therapeutic equivalency.
Mallinckrodt, the maker of the generic ADHD drug, was informed its version of Concerta was not up to par after the FDA tested it. The testing was made possible by the Generic Drug User Fee Act, according to FiercePharma.
Basically, the generic ADHD drug did not meet Concerta’s extent and rate of absorption in the same conditions and time frame. According to the Regulatory Affairs Professionals Society, the FDA explained what it looks for when testing a generic drug against a brand name, or pioneer, drug.
“The generic version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the pioneer drug.”
As a result of the generic ADHD drug not meeting acceptable standards, the FDA labeled Mallinckrodt’s drug not “readily substitutable” to replace the standard Concerta ADHD medication.
Mallinckrodt does not believe the FDA’s assessment of its generic ADHD medication is correct, and considers its drug to be safe and effective for patients.
“We believe that the FDA’s actions are not supported by sound scientific evidence and not consistent with the best interests of patients,” CEO Mark Trudeau said in a statement.
Mallinckrodt is a Dublin-based drug maker which has met all quality specifications and the regulatory requirements first made clear by the FDA, according to Business Wire. The generic version of Concerta had been on shelves for about 21 months, and about 88 million doses of the generic ADHD medication have been prescribed.
“Based on our review of Mallinckrodt’s safety database and the conclusions FDA has shared with the company, we remain confident in the safety of our methylphenidate ER products,” Trudeau said.
The company wants the FDA to reconsider its findings. It also wants to keep patients’ fears of their generic drug at bay, and warned shortages for ADHD medication could happen if their product is taken off the shelves.
“In the face of the agency’s precipitous decision, Mallinckrodt will continue to defend the safety and efficacy of our methylphenidate products,” said Trudeau. “We are considering all of our options to persuade the agency to engage in a meaningful dialog with us regarding the science, including potential legal action.”
Mallinckrodt’s shares fell 7 percent after the FDA published its findings about the generic ADHD drug last week.
[Image via Geeky Gadgets]