The FDA has approved the firm’s ANDA for Lisdexamfetamine Dimesylate Capsules 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg
Mallinckrodt secures FDA approval for generic ADHD drug Lisdexamfetamine Dimesylate Capsules. (Credit: Raman Oza from Pixabay)
Mallinckrodt’s speciality generics unit SpecGx has received the US Food and Drug Administration (FDA) approval for its Lisdexamfetamine Dimesylate Capsules to treat attention-deficit/hyperactivity disorder (ADHD).
Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) for the treatment of ADHD and other indications.
The FDA has approved the firm’s Abbreviated New Drug Application (ANDA) for Lisdexamfetamine Dimesylate Capsules 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg.
The US health regulator found that SpecGx’s offering was bioequivalent and therapeutically equivalent to the reference listed drug (RLD) Vyvanse Capsules of Takeda Pharmaceuticals. This is across all seven of the RLD’s approved strengths.
Mallinckrodt executive vice president and speciality generics head 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.”
Mallinckrodt, a global speciality pharmaceutical company, launched the product’s immediate commercialisation a day after the paediatric exclusivity granted to the RLD expired.
The generic version of Vyvanse Capsules is produced at SpecGx’s facility in Hobart, New York, using an active pharmaceutical ingredient (API) produced at its facility in St. Louis, Missouri.
Mallinckrodt has multiple fully-owned subsidiaries that develop, manufacture, commercialise and distribute speciality pharmaceutical products and therapies.