Mallinckrodt, a global specialty pharmaceutical company, has made waves with an announcement that’s set to reshape the Attention-Deficit/Hyperactivity Disorder (ADHD) treatment arena. On August 25, 2023, their Specialty Generics arm, SpecGx LLC, achieved a momentous milestone—approval from the United States Food and Drug Administration (FDA). Their golden ticket? An Abbreviated New Drug Application for Lisdexamfetamine Dimesylate Capsules, available in a range of strengths from 10mg to 70mg.
The FDA, in its wisdom, has declared that SpecGx LLC’s creation is not just similar but virtually identical, both biologically and therapeutically, to Vyvanse Capsules, the gold standard crafted by Takeda Pharmaceuticals USA. This marks a giant leap for SpecGx LLC into the realm of pharmaceutical equivalence.
Lisdexamfetamine Dimesylate Capsules, often known as a federally controlled substance (CII), serve as a lifeline for individuals grappling with ADHD. These capsules, now blessed with the FDA’s nod, also cater to other indications and find themselves in high demand. In fact, they’ve been so sought after that they’ve earned a spot on the FDA’s drug shortage list. It’s a testament to their importance and effectiveness.
“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.”
– Stephen Welch, Executive Vice President and Head of Specialty Generics
But it’s not just about medical need; it’s also a business move of profound significance. The global net sales of Lisdexamfetamine Dimesylate soared to a staggering $3.0 billion in Takeda’s fiscal year, culminating on March 31, 2023. That’s not just a number; it’s a reflection of the profound impact these capsules have on the lives of those they serve.
What’s more intriguing is the timing of this approval. It came hot on the heels of the expiration of the RLD’s (Reference Listed Drug) pediatric exclusivity. It’s as though Mallinckrodt saw an opportunity and seized it, stepping in the day after the door of exclusivity closed. It’s a testament to their strategic acumen and their commitment to delivering vital medications to those in need.
The story doesn’t end with approval. In fact, it’s just the beginning. Mallinckrodt wasted no time and sprang into action, initiating the commercialization of their newly approved product with urgency. These generic capsules, crafted by SpecGx LLC, come to life in the heart of Hobart, New York, where meticulous manufacturing practices ensure top-notch quality. The active pharmaceutical ingredient that forms the core of these capsules is no less important. It’s produced with precision at Mallinckrodt’s plant in St. Louis, Missouri.