Mallinckrodt’s specialty generics segment, operating as SpecGx, has received approval from the Food and Drug Administration for Lisdexamfetamine Dimesylate capsules in dosage strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg. The medication is the generic of Takeda’s Vyvanse.
Lisdexamfetamine Dimesylate capsules are a federally controlled substance used to treat Attention-Deficit/Hyperactivity Disorder and other indications and they currently are on the FDA's drug shortage list.
Global net sales of Lisdexamfetamine Dimesylate exceeded $3 billion in Takeda's fiscal year ended March 31, 2023, Mallinckrodt said.
Upon receiving approval, which came the day following the expiration of the RLD's pediatric exclusivity, Mallinckrodt began immediate commercialization of the product. SpecGx's generic version is manufactured at its plant in Hobart, N.Y. utilizing active pharmaceutical ingredients manufactured at its plant in St. Louis, Mo.
"Lisdexamfetamine Dimesylate is included among the ADHD medications currently on the FDA's drug shortage list, so we are very pleased to be able to launch this product at this time to help address a critical need in the market," said Stephen Welch, executive vice president and head of specialty generics. "We will be working closely with the Drug Enforcement Administration to request and secure additional quota to increase our production following this approval because we understand the vital importance of patient access to affordable, high-quality generic ADHD medicines."