Saxagliptin Hydrochloride/Metformin Hydrochloride

HYDERABAD, India--(BUSINESS WIRE)-- Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced its launch of Saxagliptin and Metformin Hydrochloride Extended-Release Tablets in the U.S. market, a therapeutic equivalent generic version of KOMBIGLYZE® XR (saxagliptin and metformin hydrochloride extended release) tablets, approved by U. S. Food and Drug Administration (USFDA). Dr. Reddy’s Saxagliptin and Metformin Hydrochloride Extended-Release Tablets are supplied in a strength of 2.5 mg/1000 mg in bottle count of 60 and strengths of 5 mg/500 mg and 5 mg/1000 mg each in bottle counts of 30. Please click here to see the full prescribing information, including boxed warning: . WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL. (5.1) Risk factors include renal impairment, concomitant use of certain drugs, age >65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high-risk groups are provided in the Full Prescribing Information. (5.1) If lactic acidosis is suspected, discontinue saxagliptin and metformin hydrochloride extended-release tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. (5.1) KOMBIGLYZE® is a registered trademark of the AstraZeneca group of companies. RDY-0723-570 About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: . Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults, currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2023. The company assumes no obligation to update any information contained herein.

April 10, 2015 By Alex Keown , BioSpace.com Breaking News Staff WASHINGTON – AstraZeneca PLC ’s diabetes drug Onglyza may cause an increased rate of death, a U.S. Food and Drug Administration panel said, Reuters reported Friday morning . The FDA released a preliminary report today , ahead of a scheduled April 14 advisory committee meeting set to discuss the drug’s safety. Onglyza was approved in 2009. The FDA began its investigation following a company-sponsored trial of more than 16,000 patients known as SAVOR showed 27 percent patients taking Onglyza, also known as saxagliptin, had an increased risk of hospitalizations due to heart failure, Reuters reported. The review found patients who took the drug incurred “a significantly increased risk of all-cause mortality.” The FDA said causes of death in the patients may have had numerous factors, including multiple medical conditions that played a role.’ In addition to AstraZeneca’s Onglyza, the FDA will also examine Takeda Pharmaceutical Co. ’s Nesina. Both drugs are known as DPP-4 inhibitors. The FDA staff didn’t find an increase in deaths related to Nesina, according to the report. The FDA said it was concerned by the increased risk. Additionally the FDA report said the panel did “not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance.” The FDA requested the new data following a study published in the “New England Journal of Medicine,” which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough due to use of saxagliptin. In 2008 the FDA recommended manufacturers of Type 2 diabetes drugs provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The FDA said it was important to “better understand the safety of new antidiabetic drugs.” Patients with diabetes have a two- to four-times greater risk of heart disease than their non-diabetic counterparts, and none of the currently approved antidiabetic therapies has been convincingly proven to reduce that risk. Because diabetes often requires life-long treatment, prescribers and patients need to know more about whether their antidiabetic therapies put patients at increased risk of heart attack, the FDA said. were slightly down this morning at $69.65 per share from the day’s high of $69.73. In 2014 Onglyza generated $820 million in sales for AstraZeneca last year, while Nesina, which was approved in 2013, generated $403 million for Japan-based Takeda last year. Another diabetes drug undergoing testing is Januvia, manufactured by Merck and Co. , which brought in $3.93 billion in sales last year, according to Bloomberg . More than 23 million people in the United States have been diagnosed with Type 2 diabetes or diabetes mellitus, a chronic metabolic disorder characterized by abnormally high blood sugar levels known as hyperglycemia. In addition to Onglyza AstraZeneca, working at the time with Bristol-Myers Squibb , manufactures Kombiglyze XR for the treatment of Type 2 diabetes in adults. The drug was approved by the FDA in 2010. BioSpace Temperature Poll After last week’s news that Gilead had issued a health advisory to doctors , concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next? var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "after-injuries-death-what-penalty-will-gilead-pay", placeholder: "pd_1428015984" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed'));