Articles from Amneal Pharmaceuticals, Inc.
Amneal to Participate at Upcoming Investor Conferences
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, announced today that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate in two upcoming investor conferences.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · December 4, 2024
Amneal Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide, its First Generic Injectable GLP-1 Agonist
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, today announced the advancement of two key strategic initiatives. First, the Company has resubmitted to the U.S. Food and Drug Administration (FDA) its new drug application (NDA) for dihydroergotamine (DHE) prefilled syringe autoinjector for the acute treatment of migraine with or without aura and cluster headache in adults. Second, Amneal has received approval from the FDA for exenatide, which is the Company’s first generic injectable glucagon-like peptide-1 (GLP-1) agonist and reflects its innovation capabilities in peptide development and drug-device combinations.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · November 21, 2024
Amneal Reports Third Quarter 2024 Financial Results
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced its results for the third quarter ended September 30, 2024.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · November 8, 2024
Amneal Receives U.S. FDA Approval of New Drug Application for Pyridostigmine Bromide Extended-Release Tablets
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company based in the U.S., today announced that it has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · October 21, 2024
Amneal to Report Third Quarter 2024 Results on November 8, 2024
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that the Company will release its third quarter 2024 financial results on Friday, November 8, 2024, prior to market open. The Company will host a conference call and live webcast with the investment community at 8:30 a.m. Eastern Time.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · October 8, 2024
Amneal and Metsera Announce Strategic Collaboration to Develop and Supply Portfolio of Next-Generation Medicines for Obesity and Metabolic Diseases
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, and Metsera, Inc. (“Metsera”), a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, today announced that they have entered into a collaboration agreement to enable the efficient development and large-scale supply of a portfolio of new weight loss medicines globally.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · October 1, 2024
Amneal Launches CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules for Treatment of Parkinson’s Disease
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has launched CREXONT® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease. CREXONT® is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release granules and extended-release pellets. CREXONT is now broadly available at U.S. pharmacies.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · September 23, 2024
Amneal and Shilpa Announce U.S. FDA Approval of BORUZU™, the First Ready-to-Use Version of Bortezomib for subcutaneous administration
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) and Shilpa Medicare Limited (“Shilpa”) announced U.S. Food and Drug Administration (FDA) approval of BORUZU™, a new presentation of bortezomib for ready-to-use subcutaneous administration or intravenous (IV) administration. This new ready-to-use oncology product reduces the compounding preparation steps typically required with administration.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · September 5, 2024
Amneal Receives U.S. FDA Approval for Propofol Injectable Emulsion Single Dose Vials
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (FDA) for Propofol Injectable Emulsion USP, 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1,000 mg/100 mL (10 mg/mL), Single-Dose Vials.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · August 20, 2024
Amneal Reports Second Quarter 2024 Financial Results
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced its results today for the second quarter ended June 30, 2024.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · August 9, 2024
Amneal Receives U.S. FDA Approval for IPX203 for Treatment of Parkinson’s Disease to Be Launched as CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved CREXONT® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). CREXONT is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release (ER) pellets.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · August 7, 2024
Amneal Receives U.S. FDA Approval for Potassium Phosphates Injection IV Bags
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has received New Drug Application (“NDA”) approval from the U.S. Food and Drug Administration (FDA) for its new presentation of potassium phosphates in 0.9% sodium chloride injection intravenous (IV) ready-to-use (RTU) bags. This sterile presentation reduces the compounding steps for clinicians typically required with administering the product.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · July 29, 2024
Amneal to Report Second Quarter 2024 Results on August 9, 2024
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that the Company will release its second quarter 2024 financial results on Friday, August 9, 2024, prior to market open. The Company will host a conference call and live webcast with the investment community at 8:30 a.m. Eastern Time.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · July 11, 2024
Amneal Launches FOCINVEZ™, the First Ready-to-Use Version of Fosaprepitant
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced the launch of FOCINVEZ™, a ready-to-use injectable. Unlike other versions of fosaprepitant, this single-dose vial product is free of Polysorbate 80 and does not require reconstitution or dilution and can be administered directly from the vial using the included vial hanger.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · July 9, 2024
Amneal Expands Biosimilars Portfolio to Eight Products with Addition of Omalizumab Biosimilar
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the addition of omalizumab, referencing XOLAIR®, to its biosimilar pipeline.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · July 1, 2024
Amneal Releases 2023 Environmental, Social and Governance Report
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the release of its fourth (2023) Environmental, Social and Governance (ESG) Report. This 2023 report provides a look at our progress against our core ESG priorities, including our commitment to embedding sustainability across our business; human capital management, including well-being, inclusion and belonging efforts; philanthropic partnerships with health-related non-profits; corporate governance and oversight over ESG strategy and risks; and improving access to essential medicines globally.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · June 28, 2024
Amneal Expands Broad Injectables Portfolio to Over 40 Products with the Addition of Six New Therapies
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the continued expansion of its injectables portfolio with six new injectable product launches during the second quarter of 2024, bringing the Company’s total number of commercial injectable products available for the U.S. institutional market to over 40.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · June 5, 2024
Amneal Begins Supplying Over-the-Counter Naloxone Hydrochloride Nasal Spray to U.S. Retail Pharmacies and the State of California
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has begun supplying its over-the-counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg to U.S. retail pharmacies and the State of California. The product is now available for direct distribution to states and municipalities across the U.S.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · May 22, 2024
Amneal to Participate at Upcoming Investor Conference
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) announced today that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate in the 2024 Jefferies Healthcare Conference on June 5, 2024.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · May 22, 2024
Amneal Reports First Quarter 2024 Financial Results
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced its results today for the first quarter ended March 31, 2024.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · May 3, 2024
Amneal Announces U.S. FDA Approval of Over-the-Counter Naloxone Hydrochloride Nasal Spray for Emergency Treatment of an Opioid Overdose
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the availability of Over the Counter (“OTC”) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg, following Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”). Amneal’s Naloxone HCI Nasal Spray, manufactured in the U.S., is a generic equivalent to OTC NARCAN® HCI Nasal Spray, a medication that is widely used to help treat drug overdose from opioids, including heroin, fentanyl and prescription opioid medications.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · April 24, 2024
Amneal Launches PEMRYDI RTU®, the First Ready-to-Use Version of Important Oncology Injectable Medicine
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the launch of PEMRYDI RTU®, the first and only ready-to-use presentation of pemetrexed for injection. This product does not require reconstitution, dilution, or refrigeration, which is different than other versions of pemetrexed for injection.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · April 16, 2024
Amneal to Report First Quarter 2024 Results on May 3, 2024
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that the Company will release its first quarter 2024 financial results on Friday, May 3, 2024, prior to market open. The Company will host a conference call and live webcast with the investment community at 8:30 a.m. Eastern Time.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · April 10, 2024
Amneal to Ring the Nasdaq Closing Bell on April 2, 2024
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, today announced that Chirag and Chintu Patel, Co-founders and Co-Chief Executive Officers, will ring the Nasdaq closing bell on Tuesday, April 2, 2024.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · March 28, 2024
Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension. This product is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, and is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · March 25, 2024