AMRX News

Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension

AMRX

(NASDAQ:AMRX) 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 eligible for 180-day exclusivity under the FDA’s Competitive Generic Therapy (CGT) designation. Product launch is planned for the fourth quarter of 2025.

Amneal Pharma Announces FDA Approval For Prednisolone Acetate Ophthalmic Suspension; Product Launch Planned For Q3 2025

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June 12, 2025
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Amneal Receives FDA Approval For Prednisolone Acetate Ophthalmic Suspension

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June 12, 2025
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Goldman Sachs Bullish On Branded Drug Upside At Teva: What About Viatris?

AMRX

Goldman Sachs initiates Teva, Viatris, and Amneal, highlighting branded growth and pipeline strength, but one company's unclear outlook.

June 6, 2025
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Amneal Pharmaceuticals Receives FDA Approval For Brekiya Injection In Acute Treatment Of Migraine And Cluster Headaches In Adults

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May 15, 2025
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Amneal And Apiject Enters Partnership To Expand Sterile And Blow-Fill-Seal Capabilities For Advanced Pharmaceutical Manufacturing In The U.S.

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May 8, 2025
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Drug Maker Amneal Highlights Strong Commercial Uptake For Parkinson's Drug But Q1 Earnings Are Mixed

AMRX

Amneal Pharmaceuticals reported first-quarter 2025 adjusted earnings per share of 21 cents, up from 14 cents a year ago.

May 2, 2025
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Amneal Pharmaceuticals Affirms FY2025 Adj EPS Guidance of $0.65-$0.70 vs $0.68 Est; Affirms FY2025 Sales Guidance of $3.00B-$3.10B vs $3.03B Est

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May 2, 2025
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Amneal Pharmaceuticals Q1 Adj. EPS $0.21 Beats $0.15 Estimate, Sales $695.42M Miss $715.49M Estimate

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May 2, 2025
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Examining the Future: Amneal Pharmaceuticals's Earnings Outlook

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May 1, 2025
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Amneal's Combination Drug Shows Improved Sleep Quality In Parkinson's Disease Patients

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Amneal shares data showing Crexont improves sleep and motor symptoms in Parkinson's patients, with Phase 4 trial underway for further evaluation.

April 7, 2025
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Amneal's CREXONT Shows Sleep Benefits for Parkinson's Patients in Phase 3 Study

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April 7, 2025
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Amneal Announces Expanded Coverage For CREXONT To Enhance Access For Parkinson's Disease Patients In The U.S.; Increases Insurance Coverage To Over 50% Of Covered Lives

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April 3, 2025
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Amneal Pharmaceuticals Unveils BORUZU, First Ready-To-Use Bortezomib Injection For Multiple Myeloma And Mantle Cell Lymphoma

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April 1, 2025
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Amneal And mAbxience Announces FDA Review Acceptance For Two Proposed Denosumab Biosimilars Referencing Prolia And XGEVA. FDA Target Action For the Fourth Quarter of 2025

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March 3, 2025
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Barclays Maintains Overweight on Amneal Pharmaceuticals, Raises Price Target to $11

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March 3, 2025
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Generic Drugmaker Amneal Clocks Mixed Q4 Earnings, Plans Expansion In High-Growth Areas Like Weight Loss Products, Biosimilars

AMRX

Amneal Pharmaceuticals' Q4 sales rose 18% to $730.52M, surpassing estimates, while adjusted EPS missed. The company forecasts up to $3.1B in 2025 revenue.

February 28, 2025
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Amneal Expects 2025 Revenues Of $3B-$3.1B And Adjusted EPS Of $0.65-$0.70 Versus Consensus Of $2.896B And $0.71, Respectively

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February 28, 2025
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Amneal Pharmaceuticals Q4 2024 Adj EPS $0.12 Misses $0.15 Estimate, Sales $730.52M Beat $707.55M Estimate

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February 28, 2025
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Generic Drug Maker Amneal Pharmaceuticals Is Positioned To Growth Well Ahead Of Peers, Analyst Upgrades Stock

AMRX

JP Morgan upgrades Amneal Pharmaceuticals, citing strong Crexont sales, robust generics growth, and a higher 2025 revenue forecast, with peak sales over $300 million.

February 24, 2025
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JP Morgan Upgrades Amneal Pharmaceuticals to Overweight, Raises Price Target to $12

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February 24, 2025
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Amneal Launches Mesalamine And Receives U.S. FDA Approval For Lenalidomide

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February 19, 2025
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Amneal Pharmaceuticals Expects To Meet Its 2024 Net Revenue, Adjusted EBITDA, And Adjusted EPS Guidance, Exceed Its Operating Cash Flow Guidance - Filing

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January 15, 2025
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Amneal Has Begun Supplying OTC Naloxone Hydrochloride Nasal Spray To U.S. Retail Pharmacies And The State Of California

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May 22, 2024
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Recap: Amneal Pharmaceuticals Q1 Earnings

AMRX

Amneal Pharmaceuticals (NYSE:AMRX) reported its Q1 earnings results on Wednesday, May 4, 2022 at 06:00 AM. Here's what investors need to know about the announcement.

May 4, 2022
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Amneal Pharmaceuticals's Earnings Outlook

AMRX

Amneal Pharmaceuticals (NYSE:AMRX) is set to give its latest quarterly earnings report on Wednesday, 2022-05-04. Here's what investors need to know before the announcement. Analysts estimate that Amneal Pharmaceuticals will report an earnings per share (EPS) of $0.13.

May 3, 2022
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