Latest news with #AmnealPharmaceuticals
Miami Herald
5 days ago
- Health
- Miami Herald
Urinary tract infection drug recalled. Tablets could be tainted and deadly
Three lots of a drug designed to treat various urinary tract infections have been recalled because the white round tablets might have black spots from microbial contamination. The spotting of spots 'was reported in a product quality complaint,' Amneal Pharmaceuticals said in its FDA-posted recall notice about Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg. As for what problems this might cause, Amneal's notice said: 'Oral products contaminated with Aspergillus may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections.' Sulfamethoxazole/Trimethoprim is used for UTIs caused by a broad list of strains, among which are E. coli; middle-ear infections in children; streptococcus pneumoniae aka pneumococcus, which the Cleveland Clinic says can cause pneumonia, sepsis or bacterial meningitis; and 'traveler's diarrhea.' READ MORE: USDA public health alert: E. coli found in beef sent to Whole Foods stores What exactly has been recalled? Recalled tablets with 400 mg of Sulfamethoxazole and 80 mg Trimethoprim went to wholesalers and distributors around the nation from Dec. 4 through May 15. If you have these tablets but got them before Dec. 4, you're safe. Bottles in lot No.s AM241019 and AM241020 are 100-count bottles. Bottles in lot No. AM241019A have 500 tablets. If you're taking these drugs, for instructions on returning them or to ask questions about this recall, contact Amneal at 833-582-0812, Monday through Friday, 8 am. to 5 p.m., Eastern time; email sulfamethoxazole-trimethoprim-recall@ or fax to 631-983-2595. If you experience any medical problems, tell a medical provider. Then inform the FDA's MedWatch program, either online or by downloading a form, then faxing it to 800-332-0178. If you can't download a form, call 800-332-1088 to ask for a form. Then you should report the problem to Amneal at 877-835-5472, Monday through Friday, 8 a.m. to 6 p.m., Eastern time or by emailing DrugSafety@
Yahoo
29-05-2025
- Business
- Yahoo
Amneal to Participate at Upcoming Investor Conferences in June
BRIDGEWATER, N.J., May 29, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) will participate in two upcoming investor conferences: Jefferies Global Healthcare Conference on June 5, 2025, with company presentation at 9:20 AM ET, and Goldman Sachs Global Healthcare Conference on June 10, 2025, with fireside chat at 10:40 AM ET. Chirag Patel, Co-Chief Executive Officer and President, and Tasos Konidaris, Executive Vice President and Chief Financial Officer, will participate in both conferences. A live webcast will be accessible at with replays available following both events. About AmnealAmneal 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 and follow us on LinkedIn. Investor ContactAnthony DiMeoVP, Investor in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
16-05-2025
- Business
- Yahoo
AMRX Q1 Earnings Call: Miss on Revenue, Margin Expansion, and Product Pipeline Progress
Pharmaceutical company Amneal Pharmaceuticals (NASDAQ:AMRX) fell short of the market's revenue expectations in Q1 CY2025, but sales rose 5.5% year on year to $695.4 million. On the other hand, the company's full-year revenue guidance of $3.05 billion at the midpoint came in 0.8% above analysts' estimates. Its non-GAAP profit of $0.21 per share was 43.2% above analysts' consensus estimates. Is now the time to buy AMRX? Find out in our full research report (it's free). Revenue: $695.4 million vs analyst estimates of $720.2 million (5.5% year-on-year growth, 3.4% miss) Adjusted EPS: $0.21 vs analyst estimates of $0.15 (43.2% beat) Adjusted EBITDA: $170 million vs analyst estimates of $161.7 million (24.4% margin, 5.1% beat) The company reconfirmed its revenue guidance for the full year of $3.05 billion at the midpoint Management reiterated its full-year Adjusted EPS guidance of $0.68 at the midpoint EBITDA guidance for the full year is $662.5 million at the midpoint, in line with analyst expectations Operating Margin: 14.4%, up from -1.6% in the same quarter last year Free Cash Flow was -$5.75 million compared to -$13.61 million in the same quarter last year Market Capitalization: $2.35 billion Amneal's first quarter was shaped by steady revenue growth across its core generics and branded specialty segments, with management crediting robust uptake of the Parkinson's drug CREXONT and expansion in injectables for the period's performance. The company continued to benefit from a diverse portfolio, new product launches, and a growing U.S. manufacturing footprint, while leadership cited operational efficiency initiatives and favorable product mix as factors behind the improvement in margins. Co-CEO Chirag Patel highlighted, 'We are embarking on our next phase of growth with momentum and confidence in our ability to deliver on our goals in 2025 and beyond.' Looking ahead, Amneal's management remains focused on execution across multiple growth drivers, including the scaling of its biosimilars business and the anticipated launch of additional specialty products. The company reaffirmed its full-year guidance, pointing to upcoming milestones in its injectable and biosimilar portfolios, the expansion of GLP-1 manufacturing capabilities, and further market access for CREXONT. Management stated that ongoing investments in digitization and automation support its long-term strategy of becoming a leading supplier of affordable medicines. Amneal's leadership attributed the quarter's outcome to portfolio breadth, successful new launches, and efficiency gains. Revenue missed Wall Street's expectations, but adjusted profit and margins exceeded consensus due to product mix and cost controls. CREXONT launch momentum: CREXONT, Amneal's branded Parkinson's medication, continued to exceed early expectations, with rapid market share gains and expanded insurance coverage from 30% to 60% of U.S. covered lives in six months. Management cited strong patient and provider feedback and expects CREXONT to reach peak sales between $300 million and $500 million. Injectables and new launches: The affordable medicines segment grew through a mix of complex generic and injectable product launches. The company introduced BORUZU, its fourth 505(b)(2) injectable in a year, highlighting a strategic emphasis on hospital-ready formulations that improve efficiency and reimbursement for providers. Biosimilars as a growth vector: Amneal's first three biosimilars generated $125 million in revenue in the last year. Five additional biosimilar regulatory filings are planned for this year, with a goal of vertical integration to capture more value and address a market where many biologic drugs are losing exclusivity. U.S. manufacturing as a differentiator: Leadership underscored Amneal's large U.S. manufacturing footprint, producing two-thirds of its medicines domestically. This provides supply chain resilience and a potential advantage if tariffs on imported pharmaceuticals increase. GLP-1 partnership and facility buildout: The partnership with Metsera positions Amneal as a supplier and commercial partner for next-generation weight loss (GLP-1) therapies. Construction of new peptide and oral fill-finish facilities is underway, aiming to support future supply and contract manufacturing opportunities. Management's outlook for the coming quarters is anchored in the expansion of its specialty and biosimilar portfolios, operational leverage, and continued investment in manufacturing capacity, with a focus on mitigating external risks such as tariffs. Specialty and biosimilars expansion: Growth is expected from additional launches in the specialty segment—including the DHE autoinjector for migraines—and the scaling of biosimilar offerings, which management believes will drive both revenue and margin improvement. Operational efficiency initiatives: Investments in automation, digitization, and supply chain optimization are expected to enhance margins and support cost containment, even as the company ramps up new product introductions. Tariff and regulatory risk management: The company's U.S. manufacturing base and proactive inventory and sourcing strategies are intended to limit the impact of potential tariffs or regulatory delays, though management noted that economic viability and customer acceptance of any cost increases remain important variables. David Amsellem (Piper Sandler): Asked for details on biosimilar revenue contribution and vertical integration timing; leadership confirmed a $150–$160 million target for biosimilars this year and expects vertical integration options to be finalized by early next year. David Amsellem (Piper Sandler): Inquired about the focus between complex and shortage-driven injectables; management stated they are prioritizing both equally, with ongoing launches in each area and infrastructure to support growth. Les Sulewski (Truist Securities): Queried about AvKARE's exposure to federal cuts; management responded federal cuts do not apply to pharmaceuticals and sees ongoing volume growth in government channels. Les Sulewski (Truist Securities): Asked about FDA approval timelines and CREXONT's ex-U.S. expansion; management reported no FDA delays and outlined ongoing partnerships for CREXONT in Europe, Latin America, and Asia. Chris Schott (JPMorgan): Requested insight on leverage of U.S. manufacturing in the event of tariffs; management highlighted available capacity and willingness to increase domestic production if economically justified, with discussions ongoing with major customers about sharing potential cost increases. In the quarters ahead, the StockStory team will be monitoring (1) the commercial uptake and payer coverage expansion of CREXONT and upcoming specialty launches, (2) progress on biosimilar regulatory filings and the pace of vertical integration, and (3) operational milestones related to new manufacturing facility buildouts and the GLP-1 partnership with Metsera. Sustained margin improvement and execution on complex injectable launches will also be key indicators of strategic progress. Amneal currently trades at a forward P/E ratio of 10.7×. In the wake of earnings, is it a buy or sell? Find out in our free research report. The market surged in 2024 and reached record highs after Donald Trump's presidential victory in November, but questions about new economic policies are adding much uncertainty for 2025. While the crowd speculates what might happen next, we're homing in on the companies that can succeed regardless of the political or macroeconomic environment. 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Yahoo
15-05-2025
- Health
- Yahoo
Amneal Receives U.S. FDA Approval for Brekiya® (dihydroergotamine mesylate) injection for the Acute Treatment of Migraine and Cluster Headaches in Adults
Brekiya® becomes the first and only DHE autoinjector that allows patients to self-administer the same medication used in hospitals in a ready-to-use form Product will be available for appropriate patients in the second half of 2025 BRIDGEWATER, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ('Amneal' or the 'Company') today announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya® (dihydroergotamine mesylate) injection, the first and only dihydroergotamine (DHE) autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.1,2 Brekiya autoinjector provides patients with the potential for sustained* pain relief† in a convenient, self-administered form.1,3,4 It contains the same medication (DHE) used in hospitals, now in a ready-to-use device.1,5 Brekiya autoinjector does not require refrigeration, assembly, or priming of the device.1 Patients can deliver one dose subcutaneously into the middle of the thigh.1 This may be beneficial for patients who respond inadequately to oral therapies due to lack of efficacy, experience nausea or vomiting during attacks, have gastroparesis, or delay dosing until too late into the attack.1,5,6 'We are thrilled to offer the first and only ready-to-use autoinjector for patients suffering from acute migraine and cluster headaches. Physicians are familiar with DHE, which is an effective and well-established therapy that provides sustained relief for headaches. Our single-dose autoinjector represents an innovative therapeutic option for patients that allows for quick self-administration of the medication during these painful attacks without visiting the emergency room,' said Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty. DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. DHE can be used at any point during a migraine attack, and may protect patients from headache recurrence.1,3,4 Approximately 39 million Americans are living with migraine7, and up to one million with cluster headache.8 Also, headache is the fourth most common reason for emergency department visits, and accounts for 3% of all emergency room visits in the United States.9 There are limited treatment options available for cluster headache, and Brekiya autoinjector represents a new treatment option for this underserved population.2 Do not take Brekiya autoinjector with strong CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. See additional Important Safety Information below. IndicationBrekiya autoinjector is a prescription medicine used for the acute treatment of migraine with or without aura and acute cluster headaches in adults. Brekiya autoinjector is not used to prevent migraine or used to treat other types of headaches such as hemiplegic migraines (that make you unable to move on one side of your body) or basilar migraines (rare form of migraine with aura). It is not known if Brekiya autoinjector is safe and effective in children. IMPORTANT SAFETY INFORMATIONSerious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Brekiya autoinjector) with strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together. Do not use Brekiya autoinjector if you: are taking medicines known as strong CYP3A4 inhibitors, such as: ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, ketoconazole, or itraconazole. have heart problems or a history of heart problems, or uncontrolled high blood pressure. have narrowing of blood vessels in your legs, arms, stomach, or kidneys (peripheral vascular disease). have sepsis, had vascular surgery, severe liver or kidney problems. are allergic to dihydroergotamine, ergot alkaloids, latex, or any of the ingredients in Brekiya autoinjector. have taken any of the following medicines in the last 24 hours: sumatriptan, frovatriptan, ergotamine or ergotamine-type medicines, almotriptan, naratriptan, zolmitriptan, eletriptan, or rizatriptan have taken any medicines that constrict your blood vessels or raise your blood pressure. Before you take Brekiya autoinjector, tell your healthcare provider about all your medical conditions, including if you: have high blood pressure, liver problems, or kidney problems. have risk factors for heart disease, such as: high blood pressure, high cholesterol levels, smoke, are overweight, diabetes, family history of heart disease. are pregnant or plan to become pregnant. Brekiya autoinjector may cause preterm labor. Brekiya autoinjector should be avoided during pregnancy. Talk to your healthcare provider right away if you are pregnant or want to become pregnant. are breastfeeding or plan to breastfeed. Brekiya autoinjector may reduce breast milk supply and pass into your breast milk. Brekiya autoinjector may be harmful to your baby. Do not breastfeed your baby while taking Brekiya autoinjector and for 3 days after you use Brekiya autoinjector. Talk with your healthcare provider about the best way to feed your baby if you take Brekiya autoinjector. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: sumatriptan, ergot-type medicine, saquinavir, nefazodone, fluconazole, grapefruit juice, zileuton, nicotine, propranolol or other medicines that can lower your heart rate, any medicines that can increase your blood pressure, selective serotonin reuptake inhibitors. These are not all of the medicines that could affect how Brekiya autoinjector works. Your healthcare provider can tell you if it is safe to take Brekiya autoinjector with other medicines. How should I use Brekiya autoinjector? Certain people should take their first dose of Brekiya autoinjector in their healthcare provider's office or in another medical setting. Brekiya autoinjector is for injection under the skin (subcutaneous) only. Use Brekiya autoinjector exactly as your healthcare provider tells you to use it. Each autoinjector contains one dose (1 mg). If your headache comes back after the first complete dose, you may give yourself up to 2 more doses as needed. Wait at least one hour between doses. Do not inject more than 3 doses (3 mg) of Brekiya autoinjector in a 24-hour period or 6 doses (6 mg) in a 1-week (7 day) period. What are the possible side effects of Brekiya autoinjector?Brekiya autoinjector can cause serious side effects, including: Heart attack and other heart problems. Heart problems may lead to death. Stop taking Brekiya autoinjector and get emergency medical help right away if you have any symptoms of a heart attack, such as: numbness or tingling in your fingers and toes, muscle pain or cramps in your arms and legs, weakness in your legs, temporary speeding or slowing of your heart rate, or swelling or itching. Brekiya autoinjector is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. Stroke. Stop using Brekiya autoinjector and get emergency medical help right away if you have any of the symptoms of a stroke. Changes in color or sensation in your fingers and toes (Raynaud's syndrome). Stomach and intestinal problems. Increased blood pressure. Medicine overuse headache. Some people who use too much Brekiya autoinjector may make their headaches worse. If your headaches get worse, your healthcare provider may decide to stop your treatment with Brekiya autoinjector. Preterm labor. Tissue changes (fibrotic complications). Inflammation and fiber-like tissue that is not normal (fibrosis) can occur around the lungs and stomach. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Brekiya autoinjector. Call your healthcare provider for medical advice about side effects. How should I store Brekiya autoinjector? Store at room temperature between 68°F to 77°F (20°C to 25°C). Do not refrigerate or freeze. Protect Brekiya autoinjector from light. Keep Brekiya autoinjector in the original pack until ready to use. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472, or FDA at 1-800-FDA-1088 or Please see full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use at *Sustained represents a duration of approximately 24-72 hours2,3†Cluster headache results reported using IV administration.4 References: Brekiya [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2025. Data on File. Amneal Pharmaceuticals LLC. Winner P, Ricalde O, Le Force B, Saper J, Margul B. Arch Neurol. 1996;53(2):180-184. Mather PJ, Silberstein SD, Schulman EA, Hopkins MM. Headache. 1991;31(8):525-532. Silberstein SD, Shrewsbury SB, Hoekman J. Headache. 2020;60(1):40-57. doi:10.1111/head.13700 Aurora SK, Papapetropoulos S, Kori SH, Kedar A, Abell TL. Cephalalgia. 2013;33(6):408-415. Phelan, M, Thompson NR, Zubair A et al. Emergency department utilization among patients who receive outpatient specialty care for headache: A retrospective cohort study analysis. Headache. 2023;63:472–483. Brekiya is a registered trademark of Amneal Pharmaceuticals LLC. About AmnealAmneal 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 and follow us on LinkedIn. Cautionary Statement on Forward-Looking StatementsCertain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management's intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as 'plans,' 'expects,' 'will,' 'anticipates,' 'estimates,' and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company's filings with the Securities and Exchange Commission, including under Item 1A, 'Risk Factors' in the Company's most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. Investor Contact Anthony DiMeoVP, Investor Relations ContactBrandon SkopSr. Director, Corporate PP-PRS-DHE-US-0001 05/2025Sign in to access your portfolio
Reuters
15-05-2025
- Business
- Reuters
US FDA approves Amneal's self-administered migraine treatment
May 15 (Reuters) - Amneal Pharmaceuticals (AMRX.O), opens new tab said on Thursday the U.S. Food and Drug Administration has approved its self-administered migraine drug, sending its shares up 6% in premarket trading. The drug, branded as Brekiya, comes with a pre-filled auto injector and is approved for the treatment of acute cases of migraine, a condition characterized by recurrent attacks of throbbing and pulsating pain on one side of the head. The single-dose drug can be administered by patients into the middle of the thigh and does not require refrigeration or assembly of the device, the company said. Brekiya will be available in the U.S. by the second half of the year, Amneal said.
