Amneal Receives U.S. FDA Tentative Approval for Beclomethasone Dipropionate HFA Inhalation Aerosol
Amneal (NYSE:AMRX) announced on October 29, 2025 that the U.S. Food and Drug Administration has provided tentative approval for its ANDA for beclomethasone dipropionate HFA inhalation aerosol in 40 mcg and 80 mcg strengths.
The product is the generic equivalent of QVAR and is indicated as maintenance prophylactic therapy for asthma in patients five years and older (not for acute bronchospasm). This is Amneal’s first metered‑dose inhaler (MDI), marking an expansion into complex respiratory therapies. IQVIA U.S. annual sales for the branded product were approximately $329 million for the 12 months ended August 2025.
Amneal (NYSE:AMRX) ha annunciato il 29 ottobre 2025 che la Food and Drug Administration degli Stati Uniti ha fornito una approvazione provvisoria per la sua ANDA per il beclometasone difpropionato HFA in aerosol inalatorio nelle dosi di 40 mcg e 80 mcg.
Il prodotto è l'equivalente generico di QVAR ed è indicato come terapia di mantenimento profilattica per l'asma in pazienti di età a partire da cinque anni e oltre (non per broncospasmo acuto). Questo è il primo inalatore dose‑misurata (MDI) di Amneal, segnando un'espansione nelle terapie respiratorie complesse. Le vendite annue IQVIA negli Stati Uniti per il prodotto marchiato ammontavano a circa $329 milioni per i 12 mesi terminati ad agosto 2025.
Amneal (NYSE:AMRX) anunció el 29 de octubre de 2025 que la Administración de Alimentos y Medicamentos de los Estados Unidos ha otorgado una aprobación provisional para su ANDA de beclometasona dipropionato HFA en aerosol inhalado en dosis de 40 mcg y 80 mcg.
El producto es el equivalente genérico de QVAR y está indicado como terapia profiláctica de mantenimiento para el asma en pacientes de cinco años en adelante (no para broncoespasmo agudo). Este es el primer inhalador de dosis medida (MDI) de Amneal, lo que marca una expansión hacia terapias respiratorias complejas. Las ventas annuas IQVIA en EE. UU. para el producto de marca fueron aproximadamente $329 millones para los 12 meses terminados en agosto de 2025.
Amneal (NYSE:AMRX)가 2025년 10월 29일에 미국 식품의약국(FDA)이 비클로메타손 디프로피오네이트 HFA 흡입용 에어로졸의 ANDA에 대해 잠정 승인을 제공했다고 발표했습니다. 용량은 40 mcg 및 80 mcg입니다.
이 제품은 QVAR의 제네릭 등가물이며 다섯 살 이상의 천식 유지 요법으로 지시됩니다(급성 기관지 경련에는 해당되지 않음). 이것은 Amneal의 첫 분무식 흡입기(MDI)로, 복합 호흡기 치료로의 확장을 의미합니다. 브랜드 제품에 대한 IQVIA 미국 연간 매출은 2025년 8월 종료 12개월 동안 약 $329 million이었습니다.
Amneal (NYSE:AMRX) a annoncé le 29 octobre 2025 que l'approbation provisoire de la FDA pour son ANDA de beclométhasone dipropionate HFA en aérosol inhalé, en dosages de 40 mcg et 80 mcg.
Le produit est l'équivalent générique de QVAR et est indiqué comme thérapie prophylactique d'entretien de l'asthme chez les patients âgés de cinq ans et plus (pas pour le bronchospasme aigu). Il s'agit du premier inhalateur-doseur (MDI) d'Amneal, marquant une expansion vers les thérapeuties respiratoires complexes. Les ventes annuelles IQVIA américaines pour le produit de marque s'élevaient à environ $329 millions pour les 12 mois terminés en août 2025.
Amneal (NYSE:AMRX) gab am 29. Oktober 2025 bekannt, dass die US‑Food and Drug Administration eine vorläufige Zulassung für seine ANDA beclomethasone dipropionate HFA Inhalations-Aerosol in den Stärken 40 mcg und 80 mcg erteilt hat.
Das Produkt ist das generische Äquivalent zu QVAR und ist als Erhaltungstherapie zur Prophylaxe von Asthma bei Patienten fünf Jahre und älter vorgesehen (nicht für akute Bronchospasmen). Dies ist Amneal’s erstes dosengesteuertes Inhalationsgerät (MDI), was eine Expansion in komplexe Atemwegstherapien markiert. IQVIA US jährliche Verkäufe für das Markenprodukt beliefen sich auf ungefähr $329 Millionen für die 12 Monate bis August 2025.
Amneal (NYSE:AMRX) أعلنت في 29 أكتوبر 2025 أن إدارة الغذاء والدواء الأمريكية قدمت الموافقة المؤقتة على ANDA الخاص بها لبخاخ beclomethasone dipropionate HFA للاستنشاق في جرعات 40 ميكغ و 80 ميكغ.
المنتج هو المعادل الجنيري لـ QVAR ومذكور كعلاج وقائي صيانة للربو لدى مرضى خمس سنوات فأكبر (ليس للربو القصبي الحاد). وهذا هو أول جهاز استنشاق مقنن الجرعة (MDI) من Amneal، ما يمثل توسعًا في العلاجات التنفسية المعقدة. بلغت مبيعات IQVIA الأمريكية السنوية للمنتج ذو العلامة التجارية نحو $329 مليون خلال 12 شهرًا المنتهية في أغسطس 2025.
Amneal (NYSE:AMRX) 于 2025年10月29日宣布，美国食品药品监督管理局已就其 beclomethasone dipropionate HFA 吸入性气溶胶的 ANDA 提供了 初步批准，剂量为 40 μg 和 80 μg。
该产品是 QVAR 的通用等效品，被指示作为哮喘患者（5岁及以上）的维持性预防治疗（不适用于急性支气管痉挛）。这是 Amneal 的 首款定量吸入器（MDI），标志着在复杂呼吸治疗领域的拓展。IQVIA 美国区域该品牌产品的年销售额在截至 2025 年 8 月的 12 个月内约为 $329 million。
- First MDI product for Amneal, expanding product portfolio
- Entry into complex respiratory therapies opens new growth vector
- Branded market size: $329M U.S. annual sales (12 months ended Aug 2025)
- Tentative FDA approval (not final marketing approval)
- Product not indicated for relief of acute bronchospasm
- Common adverse reactions include headache and upper respiratory infection
Insights
FDA tentative approval opens Amneal’s first MDI respiratory franchise and creates a new growth vector.
Amneal achieved tentative approval for a generic of QVAR (beclomethasone dipropionate HFA) in two strengths, representing its first metered‑dose inhaler (MDI) product and a move into more complex respiratory manufacturing. This converts respiratory capability into a product that directly addresses maintenance asthma therapy for patients aged five and older.
Regulatory and commercial dependencies include completion of any remaining FDA requirements before full approval and launch timing relative to existing brand/generic competition; these will determine market entry speed and initial uptake. Watch the conversion from tentative to final approval and any listed-patent or exclusivity hurdles over the next 3–12 months for signals about launch timing and revenue recognition.
Product targets a material US market (~
The generic addresses a defined maintenance asthma indication and cites annual U.S. sales of about
Key risks include the tentative approval status and timing to commercialization, competitor generic supply, and real-world prescribing shifts; expect clearer commercial impact once final approval, launch date, and initial contracting outcomes are disclosed within the next
Company’s first metered-dose inhalation (MDI) product and establishes a new growth vector for the Affordable Medicines segment
BRIDGEWATER, N.J., Oct. 29, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has tentatively approved the Company’s Abbreviated New Drug Application (ANDA) for beclomethasone dipropionate HFA inhalation aerosol (40 mcg/actuation and 80 mcg/actuation). The product is the generic equivalent of QVAR® (beclomethasone dipropionate HFA) inhalation aerosol, a registered trademark of IVAX LLC, a member of the Teva Group.
Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for the maintenance treatment of asthma as prophylactic therapy in patients five years of age and older. It is not indicated for the relief of acute bronchospasm.
This represents Amneal’s first metered-dose inhaler (MDI) inhalation product, marking a significant milestone in the Company’s expansion into complex respiratory therapies.
“Our first metered-dose inhalation product is a landmark achievement for Amneal,” said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Affordable Medicines. “This milestone reflects years of dedicated work at our state-of-the-art respiratory facility and marks the beginning of an important new therapeutic category for Amneal. With additional inhalation programs advancing, we are well positioned to drive a new growth vector within our Affordable Medicines segment.”
The most common adverse reactions associated with beclomethasone dipropionate HFA inhalation aerosol are headache, pharyngitis; upper respiratory tract infection; rhinitis; increased asthma symptoms; and inhalation route sinusitis. For full prescribing information, please refer to the package insert here.
According to IQVIA® U.S. annual sales for beclomethasone dipropionate HFA inhalation aerosol for the 12 months ended August 2025 were approximately
Note: QVAR® is a registered trademark of IVAX LLC, a member of the Teva Group.
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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