The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday proposed withdrawing two generic versions of Janssen’s extended-release attention deficit hyperactive disorder (ADHD) drug Concerta (methylphenidate hydrochloride) two years after determining that they do not provide sufficient therapeutic effects.
The manufacturers of the two Concerta generics - Kremers Urban Pharmaceuticals, a subsidiary of the Lannett Company, and Mallinckrodt Pharmaceuticals - now have the opportunity to request a hearing on CDER’s proposal to withdraw the products from the market.
Mallinckrodt received FDA approval of its abbreviated new drug application (ANDA) in December 2012, while Kudco, which is the US agent for Kremers, received FDA approval of its ANDA in July 2013.
In November 2014, FDA first highlighted issues with Mallinckrodt’s Concerta generic versions, after receiving reports to the FDA Adverse Event Reporting System (FAERS) that described insufficient therapeutic effect of the Mallinckrodt product, particularly reports describing insufficient effect later in the day.
CDER tracked the issues from December 2013 through June 2014, ran a re-analysis of bioequivalence data and “determined that the Mallinckrodt product may deliver methylphenidate into the body at a slower rate than Concerta during the time period of 7 to 12 hours post-dosing.” Mallinckrodt then sued FDA over the determination, but in August 2015, the lawsuit was tossed by a Maryland federal judge.
Mallinckrodt, however, declined to voluntarily withdraw its generic from the market, but has not submitted data or information that confirms bioequivalence of its product to Concerta, FDA says.
Similarly, in September 2013, FAERS received reports describing insufficient effect later in the day for the Kremers generic, and in June 2014, CDER concluded that Kremers data are insufficient to determine that the generic is therapeutically equivalent to the brand name drug. FDA announced the product was not therapeutically equivalent in November 2014.
In accordance with the Food Drug & Cosmetics Act, both Mallinckrodt and Kremers may submit a request for a hearing to FDA within the next month to show why approval of their ANDAs should not be withdrawn. They also must submit all data, information and analyses upon which the request for a hearing relies within the next two months.
Mallinckrodt Pharmaceuticals; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets; Opportunity for a Hearing
Kremers Urban Pharmaceuticals Inc.; Proposal to Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets; Opportunity for a Hearing