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Drug firm <keyword id="350365" type="General" weightage="100" keywordseo="astrazeneca-india" source="Orion">AstraZeneca India</keyword> on Tuesday said it has received approval from the country's drug regulator to market the anti-diabetes medication <keyword id="2860069" type="General" weightage="80" keywordseo="dapagliflozin" source="Orion">Dapagliflozin</keyword>. The company said it has received approval from the Central Drugs Standard Control Organization (CDCSCO) for the drug indicated for diabetes patients with chronic kidney disease (CKD). <br /><br />Dapagliflozin is the first and only anti-diabetic drug approved to significantly reduce the risk of sustained eGFR (estimated Glomerular Filtration Rate), cardiovascular deaths and hospitalisations due to heart failure in adults with progressive chronic kidney disease, the drug firm said. <br /><br />The approval is applicable for both diabetic and non-diabetic CKD patients, it added. <br /><br />CKD is one of the leading causes of hospitalisation globally and in <keyword id="3658" type="General" weightage="80" keywordseo="india" source="Orion">India</keyword>, representing a significant clinical and economic burden. <br /><br />"The timely approval of Dapagliflozin from the CDCSCO committee with the additional indication is a huge boost for nephrologists across the country towards the management of progressive CKD," AstraZeneca India Vice President - Medical Affairs and Regulatory <keyword id="5752586" type="General" weightage="80" keywordseo="anil-kukreja" source="Orion">Anil Kukreja</keyword> said in a statement. <br /><br />The approval will provide the clinical community with a potential therapeutic option to arrest the progression of CKDs and address heart failures at an early stage, he added. <br /><br /><strong>SEE ALSO:<br /><a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/space/news/skyroot-aerospace-plans-to-launch-another-rocket-vikram-1-in-one-year/articleshow/95850320.cms">Skyroot Aerospace plans to launch another rocket Vikram-1, in one year</a></strong><br /><strong><a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/us-weekly-flu-hospitalisations-hit-record-high-since-2010/articleshow/95851463.cms">US weekly flu hospitalisations hit record high since 2010</a></strong>

AstraZeneca India gets approval to market anti-diabetes drug

India has borne the cross of being the world’s diabetes capital for way too long. Now, a superhero drug that could save the country’s diabetics is on its way to India, but it could drag along with it all the chaos that usually accompanies these heroes.<br /><br />Amid all the fanfare around popular weight loss drug <keyword id="19918897" type="General" weightage="20" keywordseo="Ozempic" source="keywords">Ozempic</keyword> in the West, India’s Central Drug Standard Control Organisation (CDSCO) has granted approval to Eli Lilly's <keyword id="20758984" type="General" weightage="100" keywordseo="Tirzepatide" source="keywords">Tirzepatide</keyword>. Tirzepatide will make its debut in the Indian market under the brand name <keyword id="20078155" type="General" weightage="20" keywordseo="Mounjaro" source="keywords">Mounjaro</keyword> for the treatment of type 2 diabetes. Further, it is currently under review to be sold as an obesity drug under the name <keyword id="19992558" type="General" weightage="20" keywordseo="zepbound" source="keywords">Zepbound</keyword>, as well.<br /><br />Tirzepatide’s is a novel medication that combines the benefits of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists. These properties allow Tirzepatide to mimic natural hormones responsible for regulating blood sugar levels in the body.<br />    <div type="Article" hostid="261" msid="110634839" title="Eli Lilly&amp;#39;s Wegovy rival Zepbound will help make weight-loss drug market worth $130 billion by 2030, Goldman Sachs says" mstype="2" mssubtype="0"></div><br /><h2>How Tirzepatide reduces your appetite<br /></h2>The medication works by stimulating insulin release from the pancreas in response to food intake, thereby lowering blood sugar levels after meals. Additionally, it suppresses the release of glucagon, a hormone that typically raises blood sugar levels. This dual action not only helps in managing postprandial glucose spikes but also reduces glucose production by the liver.<br /><br />Moreover, Tirzepatide slows down stomach emptying, which moderates the rate at which glucose enters the bloodstream after eating. This comprehensive approach to diabetes management extends to curbing appetite and food intake, potentially aiding in weight loss — a benefit that has garnered attention in global markets.<br /><br /><h2>How affordable is Tirzepatide?<br /></h2>The simple answer is that it’s not — at least not to the average Indian. Reports suggest that each dose of Tirzepatide will cost the consumer around Rs 20,000 per week — and the recommended dose for this drug is once a week. In a month, they will end up spending a little over Rs 80,000.<br /><br />In comparison, the retail price of other commonly sold <keyword id="22456472" type="General" weightage="20" keywordseo="type-2-diabetes-drug" source="Orion">type 2 diabetes drug</keyword> combinations like sitagliptin+pioglitazone+metformin hydrochloride and dapagliflozin+metformin+vildagliptin cost a few hundred rupees per month.<br /><br />So, it remains doubtful that the average Indian would opt for Tirzepatide to treat diabetes. The drug could, however, find a market among Indians in higher income groups that are actively looking for weight loss drugs.<br /><br />Ozempic has already found an illegal route into India via celebrities, wealthy locals and expatriates. It is also easily available in the gray market — so much so that diabetes patients in need of the drug are unable to get their hands on it due to the excessive demand.<br />    <div type="Article" hostid="261" msid="111022230" title="Top doctor warns against taking weight loss drugs such as Ozempic to get &amp;#39;beach body ready&amp;#39; for summer" mstype="2" mssubtype="0"></div><br /><h2>Side-effects of the weight loss drug<br /></h2>Despite its effectiveness, Tirzepatide does come with potential side effects — and not just on your pockets. Commonly reported adverse effects include nausea, diarrhea, decreased appetite, vomiting, and abdominal discomfort. Serious complications such as pancreatitis, low blood sugar levels, allergic reactions, vision changes and gallbladder issues are rare but require immediate medical attention if experienced.<br /><br />Before starting Tirzepatide, healthcare providers are advised to educate patients on its proper use and potential risks, particularly regarding low blood sugar management. Individuals using oral contraceptives should consult their healthcare provider, as Tirzepatide may affect their efficacy.<br /><br />For those wanting to take the drug for weight loss, it is also being said that Tirzepatide does not guarantee that individuals retain their weight even after stopping its consumption. Continued exercise and a healthy diet are necessary to remain obesity-free.<br /><br />With Eli Lilly planning to launch Mounjaro in India by 2025 due to the pending completion of ongoing regulatory reviews, it remains to be seen if Tirzepatide will fly in India or not. But it will certainly give the Indian upperclass a more legal way to lose weight.<br />    <div type="Article" hostid="261" msid="109374002" title="Another perk of weight-loss drugs? Eli Lilly&amp;#39;s Zepbound may alleviate sleep apnea, too" mstype="2" mssubtype="0"></div><br />

Weight loss and diabetes drug Tirzepatide will cost Rs 80,000 per month in India

New Delhi, March 23 () Drug firm Glenmark Pharmaceuticals on Monday said it has received tentative approval from the US health regulator for generic Dapagliflozin tablets used for treatment of type-2 diabetes.<p> The product is a generic version of AstraZeneca AB's Farxiga tablets.</p><p> "Glenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food and Drug Administration (USFDA) for Dapagliflozin tablets, 5 mg and 10 mg," Glenmark said in a filing to BSE.</p><p> Citing IQVIA sales data for the 12 month period ending January 2020, the company said Farxiga tablets, brand and all available therapeutic equivalents in strengths of 5 mg and 10 mg, achieved annual sales of approximately USD 1.8 billion.</p><p> Farxiga tablets are used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</p><p> Glenmark's current portfolio consists of 165 products authorised for distribution in the US marketplace and 45 abbreviated new drug applications pending approval with the USFDA, it added. </p> Shares of Glenmark Pharmaceuticals were trading at Rs 194 per scrip on the BSE, down 7.84 per cent from their previous close.  AKT  ABI ANSANS

Glenmark gets tentative nod from USFDA for generic type-2 diabetes tablets

<p><div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"><p class="source"><span><a href="https://pictures.reuters.com/C.aspx?VP3=SearchResult&amp;ALID=2C0FQECMXA9C#/SearchResult&amp;ALID=2C0FQECMXA9C&amp;VBID=2C0FC0GVRPEA&amp;POPUPPN=16&amp;POPUPIID=2C0FQECN4IFM">Reuters/Hazir Reka</a></span></p><p class="caption">Teargas is seen released in Kosovo parliament October 15, 2015. An opposition lawmaker in Kosovo released teargas in parliament on Thursday, the second such incident in a week in protest at a European Union-brokered accord with former master Serbia.</p></div><p></p></div></div>Here is what you need to know.</p><p><strong><a href="http://www.businessinsider.com/nestle-results-for-q3-and-the-first-9-months-of-the-year-2015-10">Nestle blames China for its lowered outlook</a>. </strong>Swiss food and drink behemoth Nestle announced sales in the Asia, Oceania and sub-Saharan Africa (AOA) regions fell by 3.1%, pinning the blame at least partially on weakness in China. According to the company's outlook, it expects full-year organic growth of "around 4.5% with improvements in margins and underlying earnings per share in constant currencies, and capital efficiency." Burberry, Jaguar Land Rover and Yum Brads are other western companies to warn on China this week.<span> </span></p><p><strong><a href="http://www.businessinsider.com/yum-brands-adds-keith-meister-to-board-2015-10">Yum Brands cut its 2015 forecast and shook up its board</a>.</strong> The fast food giant expects fourth quarter same-store-sales in China of between 0% and 4% with positive numbers coming from KFC and negative ones coming from Pizza Hut. For the full-year, it sees China same-store-sales in the <span>"low-single-digit negative." Additionally, the company announced activist investor Keith Meister will join its board of directors. Meister has previously proposed to break up the company.</span></p><p><strong><a href="http://www.businessinsider.com/r-alibaba-offers-to-buy-all-of-video-streaming-company-youku-tudou-2015-10">Alibaba wants to buy the rest of Youku Tudou</a>.</strong> Chinese online retailer Alibaba wants to buy the rest of streaming video company <span>Youku Tudou, which it doesn't already own. Alibaba has offered $26.60 per American Depository Share, a 30.2% premium from Thursday's closing price. According to Reuters, Alibaba already owns an 18.3% stake in Youku Tudou. </span></p><p><strong><a href="http://www.reuters.com/article/2015/10/16/us-astrazeneca-diabetes-idUSKCN0SA0F620151016">AstraZeneca's diabetes drug combination is being delayed</a>. </strong>Reuters reports, the Food and Drug Administration says it needs to see more clinical trial data before it can approve AstraZeneca's diabetes drug combination of <span>saxagliptin and dapagliflozin. According to Morgan Stanley, such a request could delay the drug combination's approval by a few years.</span></p><p><strong><a href="http://www.businessinsider.com/steve-wynn-on-macau-table-limits-2015-10">Wynn Resorts had a bad quarter</a>.</strong> The casino giant announced earnings of $0.86 per share, which was in-line with Wall Street estimates. However, revenue tumbled 27.3% year-over-year to $996.3 million, missing the $1.03 billion that analysts were forecasting. The casino suffered through an abysmal quarter in Macau as revenue there crashed 37.9%. Revenue from Las Vegas was down 3.9%. <span>"In my 45 years of experience, I've never seen anything like this before," said Wynn Entertainment CEO Steve Wynn.</span></p><p><strong><a href="http://www.bloomberg.com/news/articles/2015-10-15/nevada-says-fantasy-sports-must-stop-play-seek-state-licenses">Nevada says daily fantasy sports is gambling</a>. </strong>The Nevada Gaming Board says daily fantasy sports is gambling and the companies operating those websites need licenses if they want to do business in Nevada. <span>A.G. Burnett, chairman of the control board, told Bloomberg, the sites cannot accept payment from customers in Nevada until they are licensed. This follows a Wall Street Journal report indicating the <span>US Justice Department and FBI are looking into whether or not the daily fantasy sports sites are violating federal law.</span></span></p><p><span><span><strong><a href="http://www.bloomberg.com/">Kyle Bass' Jazz patent challenge was declined</a>. </strong>Kyle Bass' challenge of Jazz Pharmaceutical's Xyrem patent has been rejected. According to Bloomberg, the Patent Trial and Appeal Board told Bass his arguments aren't good enough to merit a second examination of the patent. The board also said Bass being a hedge fund manager didn't factor into the decision.<span></span></span></span></p><p><strong>Stock markets around the world continue higher. </strong>China's Shanghai Composite (+1.6%) led the way higher in Asia and Spain's IBEX (+1.1%) paces the gain in Europe. However, S&amp;P 500 futures are lower by 4.00 points at 2015.00. </p><p><strong>Economic data flow. </strong>Industrial production and capacity utilization are due out at 9:15 a.m. ET while JOLTs Job Openings and University of Michigan consumer sentiment are released at 10 a.m. ET and Net Long-Term TIC Flows crosses the wires at 4 p.m. ET. The US 10-year yield is down 2 basis points at 2.00%.</p><p><strong>Earnings reports wrap up for the week. </strong>General Electric, Honeywell, SunTrust Banks and WW Grainger are among the companies set to release their quarterly results ahead of the opening bell.</p>    <div class="margin-top">        <h3>NOW WATCH: <a href="http://www.businessinsider.com/global-market-meltdown-stocks-oil-2015-8">This is what happened the week in August when global markets plunged</a></h3>        <div>            <div>        <div class="ooyala-video-player" data-video-autoplay="false" data-video-id="F3NTU1dzpxuF4acJ9B_9g5mwKWDZ5O4E" data-player-variable="ooyalapopvideo" id="ooyalaplayer_popvideo" style="width:1280px;height:720px"></div>        </div>        </div>            </div>

You Searched For "dapagliflozin" and got 4 results

AstraZeneca India gets approval to market anti-diabetes drug

PTI

Weight loss and diabetes drug Tirzepatide will cost Rs 80,000 per month in India

Ashmita Gupta

Glenmark gets tentative nod from USFDA for generic type-2 diabetes tablets

PTI

10 things you need to know before the opening bell

Jonathan Garber

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