Shire sends application to FDA for chewable Vyvanse tablets
Shire plc recently submitted a New Drug Application (NDA) for a novel formula of Vyvanse, which would allow the company to make CII into chewable tablets, to the U.S. Food and Drug Administration (FDA).
The new formula is directed toward children, adults and adolescents who find it challenging to swallow or open regular capsules. The new chewables would give patients additional options beyond swallowing Vyvanse whole or opening and mixing the capsule with yogurt, water or orange juice.
The new chewable tablets have the same indications as Vyvanse capsules, which the FDA has already approved.
“Patients are always our top priority at Shire,” Perry Sternberg, head of neuroscience, ophthalmics and commercial excellence for Shire, said. “We’re looking forward to FDA review of this application because Vyvanse chewable tablets provide an additional option for patients who may prefer taking medication in this manner.”
Within the U.S., Vyvanse is used to treat people who are six years old and above who have Attention-Deficit and Hyperactivity Disorder (ADHD). The drug is also used to treat severe to moderate Binge Eating Disorder (BED) among adults.
The treatment is not meant to be used for weight loss. As of today, researchers have not determined if Vyvanse can be used to treat obesity.
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