The FDA has proposed withdrawing two generic versions of Janssen’s extended-release attention deficit hyperactive disorder (ADHD) drug, Concerta, from the market due to "insufficient therapeutic effects."
CDER has previously concluded that data from the two manufacturers - Kremers Urban Pharmaceuticals, a subsidiary of the Lannett Company, and Mallinckrodt Pharmaceuticals - does not sufficiently determine that the generic versions are therapeutically equivalent to the brand name drug.
The two manufacturers may submit a request for a hearing to the FDA within the next month to show why approval of their ANDAs should not be withdrawn.
Mallinckrodt received FDA approval for its ANDA in December 2012 and Kremers received FDA approval in July 2013.
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