Amneal Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate
06 Setembro 2023 - 9:00AM
Business Wire
- Key ADHD medicine on the U.S. FDA shortage product list
- Represents another high-value product approval for Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the
“Company”) today announced it has received Abbreviated New Drug
Application (ANDA) approval from the U.S. Food and Drug
Administration (“FDA”) for lisdexamfetamine dimesylate capsules, 20
mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.
Lisdexamfetamine dimesylate capsules is a generic version of
Vyvanse®. This ADHD product is currently on the U.S. FDA shortage
product list, and Amneal has already begun supplying product to the
market. Lisdexamfetamine dimesylate is indicated for the treatment
of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6
years and above and for adults with moderate to severe Binge Eating
Disorder. According to IQVIA®, U.S. annual sales for
lisdexamfetamine dimesylate for the 12 months ended June 2023 were
$5.3 billion.
Important Safety Information includes a Boxed Warning,
“CNS stimulants, including lisdexamfetamine dimesylate, other
amphetamine-containing products, and methylphenidate, have a high
potential for abuse and dependence.” For full prescribing
information, see package insert located here.
“Lisdexamfetamine dimesylate is a key ADHD medicine currently in
shortage. As the #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,” said Andrew Boyer, Executive
Vice President, Amneal Generics.
About Amneal
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in
Bridgewater, NJ, is a fully integrated global pharmaceuticals
company. We make healthy possible through the development,
manufacturing, and distribution of a diverse portfolio of
approximately 270 pharmaceutical products, primarily within the
United States. In its Generics segment, the Company is expanding
across a broad range of complex product categories and therapeutic
areas, including injectables and biosimilars. In its Specialty
segment, Amneal has a growing portfolio of branded pharmaceuticals
focused primarily on central nervous system and endocrine
disorders, with a pipeline focused on unmet needs. Through its
AvKARE segment, the Company is a distributor of pharmaceuticals and
other products for the U.S. federal government, retail, and
institutional markets. For more information, please visit
www.amneal.com.
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our ability to successfully develop, license, acquire and
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face in the pharmaceutical industry from brand and generic drug
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ability to set prices; our ability to obtain exclusive marketing
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impact of healthcare reform and changes in coverage and
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identify, make and integrate acquisitions or investments in
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impact of global economic, political or other catastrophic events;
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our obligations under a tax receivable agreement may be
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subject generally to other risks and uncertainties that are
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Investor Contact Anthony DiMeo Head of Investor Relations
anthony.dimeo@amneal.com
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