Mallinckrodt receives u.s. fda approval for lisdexamfetamine dimesylate capsules and launches product used to treat attention-deficit/hyperactivity disorder (adhd)

Dublin , aug. 31, 2023 /prnewswire/ -- mallinckrodt plc (otcmkts: mnktq), a global specialty pharmaceutical company, today announced that its specialty generics segment, operating as specgx llc, received approval on august 25, 2023 from the united states food and drug administration (fda) for its abbreviated new drug application for lisdexamfetamine dimesylate capsules 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg. the fda determined specgx llc's product was bioequivalent and therapeutically equivalent to the reference listed drug (rld), vyvanse® capsules of takeda pharmaceuticals u.s.a.
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