Latest news with #Atorvastatin
&w=3840&q=100)
Business Standard
23-05-2025
- Business
- Business Standard
Alembic Pharma receives USFDA approval for generic hypertension drug
Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for its generic version of amlodipine and atorvastatin tablets, used to treat high blood pressure. The final approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amlodipine and Atorvastatin tablets of strengths 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, the company said in a statement. These are therapeutically equivalent to the reference-listed drug product, Caduet tablets of corresponding strengths of Pharmacia and Upjohn Co LLC, it added. Alembic said it has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from the USFDA. (Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Business Standard
23-05-2025
- Business
- Business Standard
Alembic Pharma receives USFDA nod for Amlodipine and Atorvastatin Tablets
Alembic Pharmaceuticals announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Amlodipine and Atorvastatin Tablets USP. Amlodipine and Atorvastatin tablets are a combination medication used to treat high blood pressure (hypertension) and high cholesterol (hyperlipidemia). The approved product is therapeutically equivalent to the reference listed drug, Caduet Tablets, marketed by Pharmacia and Upjohn Co. LLC. The company now has a cumulative total of 223 ANDA approvals from the USFDA, including 199 final approvals and 24 tentative approvals. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24. The counter shed 0.13% to Rs 971.25 on the BSE.
Time of India
23-05-2025
- Business
- Time of India
Alembic Pharma gets USFDA nod for generic high blood pressure treatment drug
Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for its generic version of amlodipine and atorvastatin tablets, used to treat high blood pressure. The final approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amlodipine and Atorvastatin tablets of strengths 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, the company said in a statement. These are therapeutically equivalent to the reference-listed drug product, Caduet tablets of corresponding strengths of Pharmacia and Upjohn Co LLC, it added. Alembic said it has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from the USFDA.
Irish Independent
15-05-2025
- Business
- Irish Independent
Irish exports reached record level in March, due to threat of Trump tariffs
Exports to America increased the most, up by €20.3bn last month alone, to reach a total of €25.4bn. This is an increase of almost 395pc. The stockpiling is most obvious in the pharma sector, which is operating under the threat of a tariff of up to 25pc. According to trade figures released by the Central Statistics Office, the exports of medical and pharma products rose by €16.7bn, or 243pc, to €23.6bn in March. The exports would include the active pharmaceutical ingredient (API) in Mounjaro, the weight-loss drug produced by Eli Lilly, one of the world's leading pharma companies which employs over 3,500 people in Ireland across three sites. Medical and pharma represents almost two-thirds of total Irish exports. In the first quarter of 2025, amid much stockpiling in advance of Mr Trump's threatened tariff regime, Irish exports in this sector increased by 154pc to €55.9bn worth of goods. The figure for the first quarter of last year was €22bn. Of the goods exported from Ireland to America, 94pc were defined as chemicals and related products, which would include medical and pharmaceutical products. Among the other prominent exports in this category would be Sildenafil and Atorvastatin, the APIs that Pfizer produces and which are marketed as Viagra and Lipitor. Kate English, Chief Economist at Deloitte Ireland, said the March figures confirm the trend of exports to the US rising considerably in response to the threat of tariffs. 'There is a clear indication of stockpiling of medical and pharmaceutical products, with exports to the US increasing by 833pc in March 2025 compared to March last year,' she said. "With such a notable rise, this is likely to positively impact Q1 GDP data. However, will this level of export trade, driven by stockpiling, hold in the second quarter? If it doesn't, we are likely to see more noise in Q2 GDP data.' 'This will make interpreting some economic data in the first half of the year quite difficult, meaning we need to continue to monitor other frequent data points, such as consumer sentiment and savings ratios." Further evidence of the sheer volume of Irish pharma exports to America in the first quarter emerged in figures from the Census Bureau in America. Released this week they showed that the US imported a record $53bn of medical and pharma products in March, up 160pc from the same month last year, and almost double the quantity of February. Ireland accounted for $28bn of the imports in March, according to the US figures, up from $5.5bn in the same month in 2024. Robert Purdue, Head of Dealing (Ireland) at global financial services firm Ebury, said: "Irish exports went through the roof in March as businesses rushed to sell their goods, particularly chemicals and pharmaceuticals, to the US. "The sheer scale of this growth - almost doubling compared to March 2024 - demonstrates the impressive resilience and capability of Ireland's exporting sector. However, more worryingly, it suggests that Ireland is unlikely to escape the firing line of US President Trump's tariff war. "With the President targeting countries with trading surpluses with the US, and with his recent criticisms of the EU, Irish businesses will be hoping that the UK trade deal announced last week will pave the way for a fair and balanced trading arrangement between Ireland and the US.' The US administration is currently doing a Section 232 national security investigation into both drugs and semiconductors, which it is widely feared will lead to the announcement of sectoral-specific tariffs in addition to the general 10pc levy imposed by Mr Trump in April.
Telegraph
10-04-2025
- Health
- Telegraph
I've paid into the NHS my whole life. Why won't they give me a life-saving drug?
The consultant's face was grave as he looked at my blood results and surveyed the angiogram. Too grave by half. 'Tell me the truth, Doc, is it twins?' I almost quipped. But I thought better of it, because an appointment at the cardiology unit is no laughing matter. Especially not in the light of the exchange that followed. My cholesterol – most saliently my 'bad' cholesterol – was stubbornly high. Always has been, despite the fact I've been maxing out on statins for years. My narrowed arteries weren't in the best shape either, a major red flag. Oh and heart disease gallops through my family like all four horsemen of the apocalypse. It killed my father at 59, did its best to fell my mother in her early sixties and it feels like every time one of my sisters pops into A&E she emerges with a couple of stents or a triple bypass. I needed a life-saving drug that health experts estimate could save 30,000 lives. The drug, which hit the headlines when it was approved for use in the NHS way back in 2021, was inclisiran. 'It's given by injection,' my consultant explained. 'Twice in the first three months and then twice a year. You would come here to receive it, but – ' 'No buts!' I cried. 'Sign me up. I'll have it right this minute if you've got a spare syringe…' The consultant looked downcast: 'It's expensive so we have to apply for funding and you might not be deemed eligible.' Come again? I've heard of NHS rationing but – irrationally, delusionally as it transpired – never thought it would apply to me. I took a deep breath, 'How expensive? Are we talking £40,000? Should I crowdfund it?' I was genuinely taken aback. 'Around £6,000 annually to begin with,' he replied, flatly, after checking online. 'Wha-a-a-t?' I almost yelled. 'I pay far more in tax than that every single year! Just ask Rachel Reeves! If I keel over with a heart attack it will cost the NHS and the Exchequer so much more. Please, let me have it.' But it's not that simple, apparently due to a lack of joined-up thinking. Cardiovascular disease, which includes heart attack, heart failure and stroke costs the NHS around £8.3 billion in care and the economy an estimated £21 billion a year. Figures from the British Heart Foundation show that each additional year of good health achieved by a preventative intervention costs £3,800 per head; almost four times lower than the £13,500 price tag for the same outcome via NHS treatment. Yet according to the Royal Pharmaceutical Society, since 2021, fewer than 20,000 people in England have been prescribed inclisiran in primary care, despite expectations that 300,000 people would be taking it by 2024. Its launch really was a big deal. Hailed as a 'gamechanger' and 'revolutionary', inclisiran prevents death from heart attack and stroke by boosting the liver's ability to reduce 'bad' cholesterol, even in those of us who are already on statins (80mg Atorvastatin and a side order of Ezetimibe, for those who like to know these things). I have familial hypercholesterolaemia, an inherited condition that means my cholesterol levels are higher than normal and can't be controlled with daily porridge and brisk walking. A healthy level of cholesterol is below 5 mmol/L. When I first had a routine test in 2010, my GP actually phoned me on a Saturday to break the news that my score was 9.8 mmol/L and to make an urgent Monday morning appointment. Many statins and a few lifestyle overhauls later, my cholesterol hovers above and below the 6 mmol/L. The ratio of good to bad is – not good. Given my family history, inclisiran was a no brainer. But money makes the world go round. Or stop, as it turns out. Yes, the NHS may be free to users at the point of need, but it needs my taxes to bankroll that magnanimity. I've worked for more than 30 years and dutifully paid into the system (the average Brit pays nearly £220,000 in income tax alone over their working lifetime); how can it be that 'our NHS' is quibbling over life-or-death jabs? Back in the cardio unit, I was sent for more blood tests, just to check. A week later, the consultant called me. I'm not entirely sure if he was punching the air to the roar of the crowd, but there was definitely a smile in his voice. My results did make me eligible for inclisiran. Yessss! But. The 'but' being that as I haven't had a stroke or heart attack (yet) there might still be some pushback. Presumably there's a musty, dusty back office somewhere dedicated to creative penny-pinching without regard to long-term savings – whether of life or outlay. Health Secretary Wes Streeting has pledged to shift the emphasis in the NHS from sickness to prevention, tipping it towards early intervention rather than the treatment of disease. It makes sense, not least because ill health drives economic inactivity. But our overstretched health service is such a lumbering behemoth and public confidence has never been lower, meaning it's hard to have much faith that change will come swiftly or be introduced fairly across all areas of care. Each discipline will no doubt argue the case for increased funding and support; cancer, heart disease and dementia are the biggest killers. My personal worry, as I await the judgment on funding, is that individuals like me will have to do the same. So Wes, please have a heart and rubber stamp my inclisiran? I'm good for it. Or I will be if the NHS gives me the medication and lets me live.
