Mallinckrodt has announced the US Food and Drug Administration (FDA) approval for its abbreviated new drug application for Lisdexamfetamine Dimesylate Capsules in strengths 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg.
The approval was granted to the company’s Specialty Generics segment, operating as SpecGx.
Mallinckrodt started selling the product after securing approval, which happened the day after the expiration of the paediatric exclusivity of the reference listed drug (RLD).
The FDA found that SpecGx’s product is both bioequivalent and therapeutically equivalent to Takeda Pharmaceuticals U.S.A’s Vyvanse Capsules, which is the RLD, across all seven approved strengths.
Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) intended for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications. These capsules are presently on the FDA’s drug shortage list.
The generic version by SpecGx is produced at its facility in Hobart, New York. The company will use the active pharmaceutical ingredient manufactured at its plant in St. Louis, Missouri.
Lisdexamfetamine Dimesylate achieved global net sales surpassing $3bn in Takeda’s fiscal year that concluded on 31 March 2023.
Mallinckrodt Specialty Generics head and executive vice-president Stephen Welch said: “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.
“We will be working closely with the Drug Enforcement Administration (DEA) 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.”