September 11, 2023
1 min read
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Amneal Pharmaceuticals has received an abbreviated new drug application from the FDA for its lisdexamfetamine dimesylate capsules to treat ADHD in patients aged 6 years and older and moderate to severe binge-eating disorder in adults.
According to an Amneal release, lisdexamfetamine dimesylate capsules are a generic version of Vyvanse (Takeda Pharmaceuticals), which is currently on the FDA shortage product list. Amneal received FDA approval for the capsules in doses ranging from 20 mg to 70 mg and has already started releasing supply to the market.
The FDA approved an abbreviated NDA for a generic formulation of Vyvanse to treat ADHD and binge-eating disorder.
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“Lisdexamfetamine dimesylate is a key ADHD medicine currently in shortage,” Andrew Boyer, executive vice president of Amneal Generics, said in the release. “As the No. 4 U.S. generics business, we are focused on the most impactful and essential areas of pharmaceuticals. We expect to launch over 30 new medicines in 2023.”
The release also notes important safety information for the product, which includes a boxed warning that central nervous system stimulants, including lisdexamfetamine dimesylate, other amphetamine-containing products and methylphenidate, have high potential for abuse and dependence.
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