Drugs Health Pharma

First generic versions of Japan’s Takeda ADHD tabs gets FDA nod

Takeda Pharmaceutical’s subsidiary, Shire Plc., was granted an FDA nod for making generic chewable tablets to treat attention-deficit, hyperactivity disorder, and moderate to severe binge disorder in adults.

HQ Team

August 29, 2023: The US Food and Drug Administration has approved several first generics of Takeda Pharmaceutical subsidiary, Shire Plc’s Vyvanse capsules to treat attention-deficit, hyperactivity disorder, and moderate to severe binge disorder in adults.

Shire started marketing Vyvanse in 2007. While expensive, it’s one of the most prescribed and effective alternatives to the widely known Adderall.

In August 2023, Vyvanse, also known by its pharmaceutical name lisdexamfetamine dimesylate, will lose its market exclusivity. It is now possible for other manufacturers to produce and marketed the drug, increasing affordability for the people who urgently need the medication.

The first generics of Vyvanse would be used in patients having trouble paying attention, controlling impulsive behaviours — may act without thinking about what the result will be — or being overly active,

The prescribing information for lisdexamfetamine dimesylate capsules, branded by Shire as Vyvanse, must contain a boxed warning to inform healthcare providers and patients about the potential risk of abuse and dependence, according to an FDA statement.

To address continuing concerns of misuse, addiction and overdose, the FDA recently required updates to the labelling of prescription stimulants to standardise prescribing information and “clearly inform patients, caregivers, and healthcare professionals of these risks.”

Warnings and precautions

The prescribing information also includes warnings and precautions regarding serious cardiovascular reactions, blood pressure and heart rate increases, psychiatric adverse reactions, suppression of growth, peripheral vasculopathy (reduced circulation of blood flow to body parts), and serotonin syndrome (a potentially life-threatening overage of serotonin).

Attention Deficit and Hyperactivity Disorder (ADHD) is one of the most common neurodevelopmental disorders of childhood, affecting approximately 10% of children, according to an FDA statement.

It is usually first diagnosed in childhood and can last into adulthood. ADHD can be successfully managed with behavioural and pharmacological treatment, and some symptoms may improve as the child ages.

Patients with binge eating disorder have recurrent episodes of compulsive overeating during which they consume larger amounts of food than normal and experience the sense that they lack control. 

Ashamed, embarrassed

Patients with this condition eat when they aren’t hungry and often eat to the point of being uncomfortably full. 

Patients may feel ashamed and embarrassed by how much they are eating, which can result in social isolation. The disorder may lead to weight gain and to other health problems.

The FDA stated that drugs that increase the levels of certain chemicals in the brain, such as amphetamines and methylphenidate-containing products (including lisdexamfetamine dimesylate), have a high potential for abuse.

The most common side effects in children, adolescents and/or adults with ADHD taking lisdexamfetamine dimesylate capsules and chewable tablets were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting. 


In binge eating disorder the side effects in adults were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.

Takeda Pharmaceutical Co., acquired Shire Plc in August 2019. Since the acquisition, the company has doubled its revenue to nearly $30 billion for its fiscal year ended March 31, 2022, from $14.6 billion for the fiscal year ended March 31, 2018, before the tie-up was announced.

Takeda, with global headquarters in Tokyo, is one of the top-ranking pharmaceutical companies in Asia.

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