Amneal Receives U.S. FDA Approval for Epinephrine Injection in Single- and Multi-Dose Vials for U.S. Hospitals Expands Amneal’s injectables portfolio with an essential medicine used in hospitals for emergency and perioperative care BRIDGEWATER, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s epinephrine injection USP, 1 mg/mL (1 mL), in single-dose vials and 1 mg/mL (30 mL) multi-dose vials. This medicine is a critical therapy utilize...
Amneal Announces Positive Interim Phase 4 ELEVATE-PD Results With CREXONT® for Parkinson’s Disease Interim data show substantial improvements in “Good On” time compared to other oral CD/LD therapiesCREXONT delivered substantial “Off” time reductions, improved motor symptom control and provided a longer duration of benefit with each doseFindings highlight CREXONT as a key therapy in a category with limited innovationELEVATE-PD study is ongoing with longer-term data expected in 2026 BRIDGEWATER, N.J., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”...
Amneal to Participate in Upcoming Investor Conferences BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) today announced that Chirag Patel, Co-Chief Executive and President, and Tasos Konidaris, Chief Financial Officer, will participate in following upcoming investor conferences: Piper Sandler 2025 Healthcare ConferenceDate: December 3, 2025Fireside Chat: Wednesday, December 3, 2025, at 9:30AM ESTLocation: New York, NY J.P. Morgan 2026 Healthcare ConferenceDate: January 12-15, 2026Presentation: Tuesday, January 13, 2026, at 4:30PM PSTLocati...
Amneal Receives U.S. FDA Approval for Albuterol Sulfate Inhalation Aerosol Represents second complex respiratory therapeutic product approval in Q4 2025 BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s albuterol sulfate inhalation aerosol (90 mcg per actuation). The product is the generic equivalent of PROAIR® HFA (albuterol sulfate inhalation aerosol), a registered trademark of Teva Respiratory LLC. This approval foll...
Amneal Announces U.S. FDA Approval of Cyclosporine Ophthalmic Emulsion 0.05% Approval underscores Amneal’s advanced sterile manufacturing capabilities and expansion within complex ophthalmic therapies; Launch expected in Q1 2026 BRIDGEWATER, N.J., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free formulation supplied in single-use vials. The product is the generic equivalent of ...
Amneal Receives U.S. FDA Approval for Iohexol Injection First-to-market complex injectable with expected launch in Q1 2026 BRIDGEWATER, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare’s Omnipaque® (iohexol) injection. Amneal expects to launch the product in the first quarter of 2026. Iohexol is a radiographic contrast agent indicated for intrathecal, intra-a...
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Amneal Reports Third Quarter 2025 Financial Results ‒ Q3 2025 Net Revenue of $785 million; GAAP Net Income of $2 million; Diluted Income per Share of $0.01 ‒‒ Adjusted EBITDA of $160 million; Adjusted Diluted EPS of $0.17 ‒‒ Updated 2025 Full Year Guidance ‒ BRIDGEWATER, N.J., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced its results for the third quarter ended September 30, 2025. “Amneal delivered another strong quarter and updated our 2025 outlook, underscoring the strength of our diversified business and the ...
Amneal Receives U.S. FDA Tentative Approval for Beclomethasone Dipropionate HFA Inhalation Aerosol 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 th...
Amneal Launches Brekiya® – the First and Only DHE Autoinjector for Adults with Migraine With or Without Aura and Cluster Headaches Brekiya® autoinjector, a new specialty therapy from Amneal, is now available for prescription exclusively through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy BRIDGEWATER, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the U.S. commercial launch of Brekiya® (dihydroergotamine mesylate) injection, the first and only ready-to-use dihydroergotamine (DHE) autoinjector...
Amneal to Report Third Quarter 2025 Results on October 30, 2025 BRIDGEWATER, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that the Company will release its third quarter 2025 financial results on Thursday, October 30, 2025, prior to market open. The Company will host an audio webcast at 8:30 a.m. ET. The financial results and live webcast will be accessible through the Investor Relations section of the Company's website at . Individuals may register for the webcast by ...
Amneal Announces BLA Submission of Biosimilar Candidate to XOLAIR® (omalizumab) Potential first-wave entry into the $4+ billion U.S. market and an important new growth driver for Amneal BRIDGEWATER, N.J., Sept. 26, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences, LLC. XOLAIR® is a registered trademark of Novartis AG. Omalizumab, a humani...
Amneal Receives U.S. FDA Approval for Bimatoprost Ophthalmic Solution, 0.01% Important ophthalmic treatment for patients and expected to be a key growth driver for Amneal’s Affordable Medicines segment BRIDGEWATER, N.J., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01% (2.5 mL, 5 mL and 7.5 mL). The product is the generic equivalent of LUMIGAN® (bimatoprost ophthalmic solut...
Amneal Receives U.S. FDA Approval of Sodium Oxybate Oral Solution 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 o...
Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension Another addition to Amneal’s growing complex injectables portfolio reflects leadership in advanced development and manufacturing of complex pharmaceuticals BRIDGEWATER, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50 mg/vial, which references Janssen’s Risperdal Consta®. The product is...
Amneal Reports Second Quarter 2025 Financial Results ‒ Q2 2025 Net Revenue of $725 million; GAAP Net Income of $22 million; Diluted Income per Share of $0.07 ‒‒ Adjusted EBITDA of $184 million; Adjusted Diluted EPS of $0.25 ‒‒ Raising 2025 Full Year Guidance ‒‒ Full Debt Refinancing Reduces Interest Cost and Extends Maturities to 2032 ‒ BRIDGEWATER, N.J., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced its results for the second quarter ended June 30, 2025. “Amneal delivered another quarter of solid growth, strong...
Amneal Announces Proposed Refinancing of Existing Credit Agreement, including Private Offering of Senior Secured Notes Due 2032 BRIDGEWATER, N.J., July 21, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal”) (Nasdaq: AMRX) announced that its subsidiary, Amneal Pharmaceuticals LLC (the “Issuer”), is seeking to borrow $1.800 billion aggregate principal amount of new seven-year term B loans (the “new term B loans”) under a new term loan facility (the “Term Loan Facility”). The Issuer has also launched an offering of $750 million aggregate principal amount of senior secured notes...
Amneal Reports Certain Preliminary Second Quarter 2025 Financial Results – Results Reflect Continued Financial Strength and Deleveraging – BRIDGEWATER, N.J., July 21, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced certain unaudited preliminary financial results for the second quarter ended June 30, 2025. The Company plans to report actual second quarter 2025 financial results on August 5, 2025. Unaudited Preliminary Financial Results for the Second Quarter Ended June 30, 2025 Net revenue of $720 million to $730 million, ...
Amneal to Report Second Quarter 2025 Results on August 5, 2025 BRIDGEWATER, N.J., July 09, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that the Company will release its second quarter 2025 financial results on Tuesday, August 5, 2025, prior to market open. The Company will host an audio webcast at 8:30 a.m. ET. The financial results and live webcast will be accessible through the Investor Relations section of the Company's website at . Individuals may register for the webcast by cl...
Amneal Highlights Positive Topline Results from Confirmatory Clinical Study of Biosimilar Candidate to XOLAIR(R) (omalizumab), Developed by Kashiv BioSciences Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025 Poised to be among the first wave of biosimilars in the $3.9 billion U.S. omalizumab market and an important growth driver for Amneal BRIDGEWATER, N.J., June 25, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today highlighted positive topline results from a confirmatory clinical efficacy and safet...
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