Articles from Amneal Pharmaceuticals, Inc.
Amneal to Report Fourth Quarter and Full Year 2024 Results on February 28, 2025
Amneal Pharmaceuticals, Inc. (NASDAQAMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced that the Company will release its fourth quarter and full year 2024 financial results on Friday, February 28, 2025, prior to market open. The Company will host an audio webcast at 8:30 a.m. ET.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · January 29, 2025
Amneal Receives U.S. FDA Approval for Memantine/Donepezil Extended-Release Capsules and Everolimus Tablets for Oral Suspension, and Tentative U.S. FDA Approval for Rifaximin
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved memantine/donepezil 14-10 mg and 28-10 mg extended-release capsules, which references Abbvie’s NAMZARIC®, and Everolimus 2 mg, 3 mg and 5 mg extended-release capsules, which references Novartis’ AFINITOR DISPERZ®. In addition, the FDA has granted tentative approval to Amneal’s rifaximin 550 mg oral tablets, which references Bausch Health’s XIFAXAN®. The FDA approval was tentative as this product is involved in litigation.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · January 23, 2025
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. (NASDAQAMRX) 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. (NASDAQAMRX) 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. (NASDAQAMRX) (“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. (NASDAQAMRX) 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. (NASDAQAMRX) (“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
Amneal Reports Fourth Quarter and Full Year 2023 Financial Results
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced its results for the fourth quarter and full year ended December 31, 2023.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · March 1, 2024
Amneal Enters into Exclusive European Licensing Agreement with Zambon Biotech for IPX203
Amneal Pharmaceuticals, Inc. (NASDAQAMRX) (“Amneal” or the “Company”) today announced that it has entered into an exclusive licensing agreement with Zambon Biotech SA, part of the Zambon group (“Zambon”), for IPX203 in the European Union, United Kingdom, and Switzerland.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · February 27, 2024
Amneal to Participate at Upcoming Investor Conference
Amneal Pharmaceuticals, Inc. (NASDAQAMRX) announced today that Chirag Patel, Co-Chief Executive Officer, will participate in the following investor conference.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · February 13, 2024
Amneal to Report Fourth Quarter and Full Year 2023 Results on March 1, 2024
Amneal Pharmaceuticals, Inc. (NASDAQAMRX) announced today that the Company will release its fourth quarter and full year 2023 financial results on Friday, March 1, 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 · January 31, 2024
Amneal Launches Complex Generic Fluorometholone Ophthalmic Suspension
Amneal Pharmaceuticals, Inc. (NASDAQAMRX) (“Amneal” or the “Company”) today announced the approval and launch of fluorometholone ophthalmic suspension. The product received 180-day competitive generic therapy (CGT) exclusivity from the U.S. Food and Drug Administration, a status that applies to first-marketed generics of key medicines.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · January 10, 2024
Amneal Launched Record Number of 39 New Retail and Injectable Products in 2023, Including 13 in Q4 2023
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal”) today announces that it has launched 39 new retail and injectable medicines in 2023, as compared to 26 new launches in 2022.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · January 4, 2024
Amneal to Participate at the 42nd Annual J.P. Morgan Healthcare Conference
Amneal Pharmaceuticals, Inc. (NYSEAMRX) announced today that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate in the 42nd Annual J.P. Morgan Healthcare Conference on January 9-10, 2024. Chirag will present on January 10th at 11:15 AM PST, and a live webcast will be accessible on the Company's website at https://investors.amneal.com. A replay of the webcast will be available for 30 days following the event.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · December 21, 2023
Amneal Announces Move to Nasdaq
Amneal Pharmaceuticals, Inc. (“Amneal”) (NYSEAMRX) today announced that it will transfer its stock exchange listing to the Nasdaq Stock Market (“Nasdaq”) from the New York Stock Exchange (“NYSE”). The Company expects the Nasdaq listing to occur on December 27, 2023 and will continue to trade under the current symbol “AMRX”. Upon transferring, Amneal will become part of the Nasdaq Composite Index and Nasdaq Biotechnology Index.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · December 15, 2023
Amneal and BIAL Announce U.S. Licensing Agreement for ONGENTYS® (opicapone)
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal”) and BIAL - Portela & Ca., S.A. (“BIAL”), today announced a licensing agreement where Amneal will have exclusive rights to market and distribute ONGENTYS® (opicapone) in the U.S. starting on December 18, 2023. Amneal expects to begin distribution of ONGENTYS® in early 2024.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · December 7, 2023
Amneal Expands Portfolio with Addition of Icosapent Ethyl Acid Soft Gel Capsules
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) and Strides Pharma Science Limited (“Strides”) today announced the addition of Icosapent ethyl acid soft gel capsules, a product referencing VASCEPA®. The product has been in-licensed from Strides, a global pharmaceutical manufacturer, and will be commercialized by Amneal starting in the fourth quarter of 2023.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · December 1, 2023
Amneal Reports Third Quarter 2023 Financial Results
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) announced its results today for the third quarter ended September 30, 2023.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · November 7, 2023
Amneal to Participate at Upcoming Investor Conferences
Amneal Pharmaceuticals, Inc. (NYSEAMRX) announced today that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate in the below investor conferences.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · November 3, 2023
Amneal Reports Certain Preliminary Third Quarter 2023 Financial Results and Raises Full Year 2023 Financial Guidance
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced certain unaudited preliminary financial results for the third quarter ended September 30, 2023. The Company also raised its financial guidance for the year ending December 31, 2023, which was most recently issued on August 4, 2023. The Company plans to report actual third quarter 2023 financial results on November 7, 2023.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · October 23, 2023
Amneal Adds Two Denosumab Biosimilars to U.S. Pipeline, Expanding Oncology Portfolio
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced the addition of two denosumab biosimilars referencing both Prolia® and XGEVA® to its biosimilar pipeline.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · October 12, 2023
Amneal to Report Third Quarter 2023 Results on November 7, 2023
Amneal Pharmaceuticals, Inc. (NYSEAMRX) announced today that the Company will release its third quarter 2023 financial results on Tuesday, November 7, 2023, 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 5, 2023
Amneal Receives U.S. FDA Approval for Calcium Gluconate Injection
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“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 calcium gluconate in sodium chloride injection, 1000 mg/50 mL and 2000 mg/100 mL. This injectable product is currently on the U.S. FDA shortage product list.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · September 6, 2023
Amneal Receives First Product Approval in China
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced it has received its first product approval in China. Sevelamer carbonate was approved and is expected to launch shortly. In addition, the Company expects to launch oseltamivir phosphate in China this year as well, upon approval. In total, Amneal has 6 products pending review in China with more product registrations planned over time. Since 2019, the Company has collaborated with Fosun Pharmaceuticals to bring key therapies to market in China.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · September 6, 2023
Amneal Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“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 lisdexamfetamine dimesylate capsules, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · September 6, 2023
Delegation from U.S. Department of Health and Human Services, U.S. Food and Drug Administration, and Local Government Officials Visit Amneal Manufacturing Site in India
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced that a delegation of senior members of the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) together with local government officials recently visited the Company’s manufacturing facility in Matoda, India. The visit followed the G20 Health Ministers' meeting in Gandhinagar, India on August 18 and 19, where health ministers from around the world met to discuss global health issues.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · August 29, 2023
Amneal to Participate at the 2023 Wells Fargo Healthcare Conference
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (the “Company”) today announced that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate at the 2023 Wells Fargo Healthcare Conference on September 7, 2023 in Boston. Mr. Patel will also be hosting a fireside chat at 8:00 AM Eastern Time and a live webcast will be accessible through the Investor Relations section of the Company's website at https://investors.amneal.com. A replay of the webcast will be posted shortly after the presentation and will be available for 90 days following the event.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · August 25, 2023
JAMA Neurology Publishes Phase 3 Study Results Comparing IPX203 to Immediate-Release Carbidopa/Levodopa for Parkinson’s Disease
Amneal Pharmaceuticals, Inc. (NYSEAMRX) today announced that JAMA Neurology has published results from the RISE-PD clinical study assessing the efficacy and safety of IPX203 versus optimized immediate-release carbidopa/levodopa (IR CD/LD) for the treatment of Parkinson’s disease (PD). The study met its primary and secondary endpoints finding that IPX203 provided more hours of “Good On” time per day, less “Off” time per day, and more “Good On” time per dose than optimized IR CD/LD, even when dosed less frequently. “Good On” time is defined as the sum of “On” time without dyskinesia and “On” time with non-troublesome dyskinesia. The manuscript titled, “IPX203 vs Immediate-Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Parkinson Disease,” was published online on August 14, 2023.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · August 24, 2023
Amneal Reports Second Quarter 2023 Financial Results
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) announced its results today for the second quarter ended June 30, 2023.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · August 4, 2023
Amneal Submits Abbreviated New Drug Applications to U.S. FDA for Three Key Complex Generics
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced it has submitted Abbreviated New Drug Applications (“ANDA”) to the U.S. Food and Drug Administration (FDA) for three key complex generic products, including:
By Amneal Pharmaceuticals, Inc. · Via Business Wire · July 26, 2023
Amneal to Report Second Quarter 2023 Results on August 4, 2023
Amneal Pharmaceuticals, Inc. (NYSEAMRX) announced today that the Company will release its second quarter 2023 financial results on Friday August 4, 2023, 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 on August 4, 2023.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · July 6, 2023
Amneal Launches Authorized Generic for Xyrem® (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced the launch of its authorized generic for Xyrem®1 (Sodium Oxybate) oral solution CIII in the United States. Sodium Oxybate oral solution, 0.5 g/mL is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy. In addition, the Company announced it has received Abbreviated New Drug Application (ANDA) approvals from the U.S. Food and Drug Administration (“FDA”) for five complex generics products. Three recently approved products are injectables, including dexmedetomidine injection which is currently on the U.S. FDA shortage product list.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · July 3, 2023
Amneal Receives U.S. FDA Complete Response Letter for IPX203
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for IPX203 for the treatment of Parkinson’s disease.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · July 3, 2023
Amneal Releases 2022 Environmental, Social and Governance Report Mapped to the United Nations Sustainable Development Goals
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced the release of its third annual (2022) Environmental, Social and Governance (ESG) Report. This 2022 report provides a look at our progress across our ESG focus areas, including updates to our people data and sustainability programs.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · June 15, 2023
Amneal Receives 505(b)(2) NDA Approval from FDA for PEMRYDI RTU®, a Ready-to-Use Oncology Injectable
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced the 505(b)(2) New Drug Application (NDA) approval from the U.S. Food and Drug Administration (“FDA”) for PEMRYDI RTU®. This product is the first and only ready-to-use presentation of pemetrexed for injection and does not require reconstitution, dilution, or refrigeration. This injectable will be available in three vial sizes: 100mg/10mL; 500 mg/50mL; and 1,000mg/100mL. The Company expects to launch this product in the first quarter of 2024 with a J-Code from the Centers for Medicare & Medicaid Services.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · June 14, 2023
Amneal to Participate at the 2023 Jefferies Healthcare Conference
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (the “Company”) today announced that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate at the 2023 Jefferies Healthcare Conference held on June 7, 2023 in New York City. Mr. Patel will also be hosting a presentation at 2:30 PM Eastern Time and a live webcast will be accessible through the Investor Relations section of the Company's website at https://investors.amneal.com. A replay of the webcast will be posted shortly after the presentation and will be available for 90 days following the event.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · May 24, 2023
Amneal Launches Third Biosimilar with FYLNETRA™ (pegfilgrastim-pbbk) in the United States
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced the commercial launch of FYLNETRA™ (pegfilgrastim-pbbk), a biosimilar referencing Neulasta® in a pre-filled single-dose syringe. FYLNETRA™ is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy. This product was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois. The J-Code (Q5130) from the Centers for Medicare & Medicaid Services (CMS) for FYLNETRA™ has been approved and is active.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · May 16, 2023
Amneal Reports First Quarter 2023 Financial Results
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) announced its actual results today for the first quarter ended March 31, 2023.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · May 5, 2023
Amneal to Participate at the 22nd Annual Needham Virtual Healthcare Conference
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (the “Company”) today announced that Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Chief Financial Officer, will participate at the 22nd Annual Needham Virtual Healthcare Conference held on April 19, 2023. Mr. Patel will also be hosting a fireside chat at 11:45 AM Eastern Time and a live webcast will be accessible through the Investor Relations section of the Company's website at https://investors.amneal.com. A replay of the webcast will be posted shortly after the presentation and will be available for 90 days following the event.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · April 17, 2023
Amneal Reports Certain Preliminary First Quarter 2023 Financial Results and Affirms Full Year 2023 Financial Guidance
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) announced certain unaudited preliminary financial results for the first quarter ended March 31, 2023. The Company is also affirming financial guidance for the year ending December 31, 2023, which was previously issued on March 2, 2023. The Company plans to report actual first quarter 2023 financial results on May 5, 2023.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · April 17, 2023
Amneal to Report First Quarter 2023 Results on May 5, 2023
Amneal Pharmaceuticals, Inc. (NYSEAMRX) announced today that the Company will release its first quarter 2023 financial results on Friday May 5, 2023, 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 on May 5, 2023.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · April 12, 2023
Amneal Announces U.S. FDA Filing Acceptance of Abbreviated New Drug Application for Naloxone Hydrochloride Nasal Spray, USP, 4mg
Amneal Pharmaceuticals, Inc. (NYSEAMRX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan® and is used in the treatment of a known or suspected opioid overdose emergency.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · March 2, 2023
Amneal Reports Fourth Quarter and Full Year 2022 Financial Results
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) announced its results today for the fourth quarter and full year ended December 31, 2022.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · March 2, 2023
Amneal to Report Fourth Quarter and Full Year 2022 Results on March 2, 2023
Amneal Pharmaceuticals, Inc. (NYSEAMRX) announced today that the Company will release its fourth quarter and full year 2022 financial results on Thursday March 2, 2023, 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 on March 2, 2023.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · January 31, 2023
Amneal Announces Strategic European Partnership with Orion Corporation
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced it has signed a long-term license agreement with Orion Corporation (OMXH: ORNBV & ORNAV) to commercialize a number of Amneal’s complex generic products.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · January 4, 2023
Amneal Announces 26 Generic New Product Launches in 2022 and First Injection Large Volume Bag Approval
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced that the Company has successfully launched 26 new generic products in 2022. In the fourth quarter of 2022, the Company launched 8 new generic products, including clindamycin phosphate gel 1%, ipratropium bromide nasal sprays, and prednisolone sodium phosphate oral solution.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · December 20, 2022
Amneal to Participate at Upcoming Investor Conferences
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (the “Company”) today announced that the management team will attend the following investor conferences:
By Amneal Pharmaceuticals, Inc. · Via Business Wire · November 23, 2022
Amneal Launches Second Biosimilar with RELEUKO® (filgrastim-ayow) in the United States
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced the commercial launch of RELEUKO® (filgrastim-ayow), a biosimilar referencing Neupogen®. RELEUKO® is used to treat neutropenia which is commonly experienced by patients undergoing chemotherapy. This product was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · November 22, 2022
Amneal Announces U.S. FDA Filing Acceptance of New Drug Application for IPX203 for the Treatment of Parkinson’s Disease
Amneal Pharmaceuticals, Inc. (NYSEAMRX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for IPX203 for the treatment of Parkinson’s disease (PD). IPX203 is a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · November 11, 2022
Amneal Reports Third Quarter 2022 Financial Results
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) announced its results today for the third quarter ended September 30, 2022.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · November 4, 2022
Amneal Receives FDA Approval for Leuprolide Acetate Injection
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“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 leuprolide acetate for injection.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · November 2, 2022
Amneal Expands Leadership Team with Appointment of Senior Leaders in Quality and Regulatory
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced it has appointed Reem Malki as Senior Vice President, Chief Quality Officer, and Maryll W. Toufanian as Senior Vice President, Regulatory Strategy and Policy.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · October 31, 2022
Amneal to Report Third Quarter 2022 Results on November 4, 2022
Amneal Pharmaceuticals, Inc. (NYSEAMRX) announced today that the Company will release its third quarter 2022 financial results on Friday November 4, 2022, 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 on November 4, 2022.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · October 6, 2022
Amneal Launches First Biosimilar with ALYMSYS® (bevacizumab-maly) in the United States
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced the commercial launch of ALYMSYS® (bevacizumab-maly), a biosimilar referencing Avastin®. ALYMSYS® is a vascular endothelial growth factor inhibitor used in oncology. This product was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · October 3, 2022
Amneal Appoints Gustavo Pesquin as Executive Vice President, Chief Commercial Officer – Specialty
Amneal Pharmaceuticals, Inc. (NYSEAMRX) (“Amneal” or the “Company”) today announced it has appointed Gustavo Pesquin as Executive Vice President, Chief Commercial Officer - Specialty, effective September 6, 2022.
By Amneal Pharmaceuticals, Inc. · Via Business Wire · September 6, 2022