Amneal Receives U.S. FDA Approval of Sodium Oxybate Oral Solution
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.
Amneal Pharmaceuticals (NYSE:AMRX) ha ottenuto l'approvazione FDA per il suo ANDA della soluzione orale di ossibato di sodio 500 mg/mL, prendendo come riferimento Xyrem® di Jazz Pharmaceuticals. Il farmaco è autorizzato per il trattamento della cataplessia o dell'eccessiva sonnolenza diurna nei pazienti con narcolessia di età pari o superiore a 7 anni.
Questa approvazione amplia il portafoglio Affordable Medicines di Amneal, proponendo un'alternativa più conveniente in un mercato in precedenza dominato da un unico produttore. Il farmaco è destinato a una condizione neurologica rara che interessa circa 150.000 persone negli Stati Uniti. In passato Amneal aveva distribuito una versione generica autorizzata in quantità limitate.
Amneal Pharmaceuticals (NYSE:AMRX) ha recibido la aprobación de la FDA para su ANDA de solución oral de oxibato sódico 500 mg/mL, con referencia a Xyrem® de Jazz Pharmaceuticals. El medicamento está aprobado para el tratamiento de la cataplexia o la somnolencia diurna excesiva en pacientes con narcolepsia de 7 años o más.
Esta aprobación amplía la cartera Affordable Medicines de Amneal, ofreciendo una alternativa más económica en un mercado antes dominado por un solo fabricante. El fármaco trata una enfermedad neurológica rara que afecta a aproximadamente 150.000 personas en Estados Unidos. Amneal había distribuido anteriormente una versión genérica autorizada en cantidades limitadas.
Amneal Pharmaceuticals (NYSE:AMRX)가 자사의 수산화소듐(옥시베이트) 경구용 용액 500 mg/mL ANDA에 대해 FDA 승인을 받았습니다. 본 제형은 Jazz Pharmaceuticals의 Xyrem®을 참조합니다. 이 약물은 7세 이상 기면증 환자의 탈력발작 또는 과도한 주간졸림증 치료에 승인되었습니다.
이번 승인은 Amneal의 Affordable Medicines 포트폴리오를 확대하여, 이전에 단일 제조사가 지배하던 시장에 더 비용 효율적인 대안을 제공합니다. 이 약물은 미국에서 약 150,000명에 영향을 미치는 희귀 신경계 질환을 대상으로 합니다. Amneal은 과거에 제한된 수량의 허가된 제네릭 제품을 유통한 바 있습니다.
Amneal Pharmaceuticals (NYSE:AMRX) a obtenu l'approbation de la FDA pour son ANDA concernant la solution orale d'oxybate de sodium 500 mg/mL, en référence à Xyrem® de Jazz Pharmaceuticals. Le médicament est approuvé pour le traitement de la cataplexie ou de l'hypersomnie diurne excessive chez les patients atteints de narcolepsie âgés de 7 ans et plus.
Cette approbation élargit le portefeuille Affordable Medicines d'Amneal, offrant une alternative plus économique sur un marché auparavant dominé par un seul fabricant. Le médicament traite une maladie neurologique rare touchant environ 150 000 personnes aux États-Unis. Amneal avait précédemment distribué une version générique autorisée en quantités limitées.
Amneal Pharmaceuticals (NYSE:AMRX) hat von der FDA die Zulassung für sein ANDA der oralen Natriumoxibat-Lösung 500 mg/mL erhalten und bezieht sich dabei auf Xyrem® von Jazz Pharmaceuticals. Das Arzneimittel ist zur Behandlung von Kataplexie oder übermäßiger Tagesmüdigkeit bei Patienten mit Narkolepsie ab 7 Jahren zugelassen.
Mit dieser Zulassung erweitert Amneal sein Affordable Medicines-Portfolio und bietet eine kostengünstigere Alternative in einem Markt, der zuvor von einem einzigen Hersteller dominiert wurde. Das Medikament richtet sich an eine seltene neurologische Erkrankung, die etwa 150.000 Menschen in den USA betrifft. Amneal hatte zuvor eine autorisierte Generikaversion in begrenzten Mengen vertrieben.
- 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
- Common adverse reactions include nausea, dizziness, vomiting, and other side effects
- Requires boxed warning indicating potential safety concerns
- Faces competition from established brand Xyrem
Insights
Amneal's FDA approval for generic sodium oxybate breaks Jazz's market dominance, expanding affordable access for narcolepsy patients.
Amneal's FDA approval of sodium oxybate oral solution represents a significant competitive development in the narcolepsy treatment market. This approval transitions Amneal from distributing limited quantities of an authorized generic to fully marketing their own ANDA-approved version of Jazz Pharmaceuticals' Xyrem
The strategic importance of this approval cannot be overstated. Sodium oxybate is considered a standard-of-care therapy for narcolepsy, which affects approximately 150,000 patients in the U.S. Jazz Pharmaceuticals has historically dominated this market with limited competition, creating a pricing environment that has been challenging for patients, providers, and payers.
For Amneal, this represents a valuable portfolio expansion into specialty neurology medications. While narcolepsy is a relatively small indication, specialty CNS medications typically command higher margins than standard generics. The company's ability to now offer a fully approved generic version should enable more competitive pricing while maintaining reasonable profitability.
From a market access perspective, Amneal's entry diversifies the supplier base for this critical medication. Given the product's status as a controlled substance with a REMS program, manufacturing and distribution complexities have limited competition. This approval potentially creates a more competitive environment that could benefit the healthcare system through improved pricing and availability.
Importantly, Amneal appears positioned to capture meaningful market share by emphasizing affordability for a medication that has historically faced limited competition. This approval aligns with the company's strategic focus on complex generics that offer higher barriers to entry and potentially better margins than conventional generic products.
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.
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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; 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.
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