Amneal Receives U.S. FDA Approval of Sodium Oxybate Oral Solution
Rhea-AI Summary
Amneal Pharmaceuticals (NYSE:AMRX) has received FDA approval for its sodium oxybate oral solution 500 mg/mL ANDA, referencing Jazz Pharmaceuticals' Xyrem®. The drug is approved for treating cataplexy or excessive daytime sleepiness in narcolepsy patients aged 7 and older.
This approval expands Amneal's Affordable Medicines portfolio, offering a more cost-effective alternative in a market previously dominated by a single manufacturer. The drug addresses a rare neurological condition affecting approximately 150,000 individuals in the United States. Amneal had previously distributed an authorized generic version in limited quantities.
Positive
- FDA approval expands Amneal's Affordable Medicines portfolio into narcolepsy treatment
- Addresses market need for 150,000 narcolepsy patients in the United States
- Breaks single-manufacturer dominance by providing more affordable treatment option
- Builds upon existing authorized generic distribution experience
Negative
- Common adverse reactions include nausea, dizziness, vomiting, and other side effects
- Requires boxed warning indicating potential safety concerns
- Faces competition from established brand Xyrem
News Market Reaction – AMRX
On the day this news was published, AMRX gained 2.75%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Expands Amneal’s Affordable Medicines portfolio and broadens patient access
BRIDGEWATER, N.J, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of Amneal’s sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA) which references Jazz Pharmaceuticals’ Xyrem®. Amneal had previously been distributing an authorized generic of sodium oxybate oral solution in limited quantities.
Sodium oxybate oral solution is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. Narcolepsy is characterized by excessive daytime sleepiness, sudden sleep attacks, and cataplexy, a sudden loss of muscle control often triggered by emotions and sodium oxybate is considered a standard of care therapy in narcolepsy due to its ability to consolidate nighttime sleep and significantly reduce cataplexy episodes.
“This approval expands Amneal’s Affordable Medicines portfolio into a critical therapy area for patients living with narcolepsy, a rare neurological condition that affects approximately 150,000 individuals in the United States,” said Tony Rosa, Senior Vice President, Retail Affordable Medicines. “By offering sodium oxybate, Amneal is providing patients, providers, and payers with a more affordable alternative in a therapeutic category that has historically been limited to a single manufacturer.”
The most common adverse reactions in adults taking sodium oxybate oral solution include nausea, dizziness, vomiting, somnolence, enuresis (bedwetting), and tremor. In pediatric patients the most common adverse events were nausea, enuresis, vomiting, headache, weight decrease, decreased appetite, dizziness, and sleepwalking. Full prescribing information including boxed warning is available here.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines 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. 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 and follow us on LinkedIn.
Cautionary Statement on Forward-Looking Statements
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; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, 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. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com
FAQ
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