Amneal Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate

 - Key ADHD medicine on the U.S. FDA shortage product list
- Represents another high-value product approval for Amneal

BRIDGEWATER, N.J.--(BUSINESS WIRE)--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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Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations, including international expansion; expected or estimated operating results and financial performance; the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements.

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Investor Contact
Anthony DiMeo
Head of Investor Relations
anthony.dimeo@amneal.com