The approval makes Wegovy the first GLP-1 therapy cleared in India for treating adults with non-cirrhotic MASH and moderate-to-advanced liver fibrosis
Novo Nordisk India on Friday said it has received approval from the Central Drugs Standard Control Organisation for indication of its Wegovy injection for the treatment of fatty liver disease in India. The Central Drugs Standard Control Organisation (CDSCO) has approved a new indication for Wegovy (semaglutide injection 2.4 mg), Novo Nordisk India said in a statement. It makes Wegovy the first and only GLP-1 RA to be approved both globally and in India for the treatment of noncirrhotic Metabolic Dysfunction Associated Steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis along with a reduced calorie diet and increased physical activity, it added. MASH is a liver disease that develops due to excess fat buildup in the liver, causing chronic inflammation and liver damage. Novo Nordisk India MD Vikrant Shrotriya said the burden of MASH continues to rise in India, but treatment options are still severely limited. People with MASH face a higher risk of serious liver .
The once-weekly basal insulin for adults with type 1 and type 2 diabetes aims to reduce the number of annual injections from 365 to 52 and address delays in insulin initiation
The drugmaker said it is monitoring its systems and maintaining normal operations after reports that a hacking group claimed to have stolen and published company data
Novo Nordisk and Eli Lilly are expanding obesity drug access globally as demand grows beyond the US and cheaper semaglutide generics enter new markets
Novo Nordisk plans to defend its obesity drug leadership in India as semaglutide patent expiry fuels competition from nearly 50 new market entrants
Global drugmakers are prioritising China and Japan for GLP-1 investments due to stronger pricing power and adoption, while India remains a large but price-sensitive market with slower premium uptake
Mounjaro sales in March dropped to ₹114 crore ($12.3 million) in March from ₹135 crore a month earlier, Pharmarack data show
Drugmaker cuts prices of injectable semaglutide brands to expand access in India, but says no similar price reduction is planned for oral semaglutide brand Rybelsus
Court allows Dr Reddy's 30 days to clear stock, after which unsold Olymviq doses will be supplied to government hospitals in presence of Novo Nordisk representative
Dr Reddy's told the Delhi High Court it plans to rebrand its diabetes drug amid a trademark dispute with Novo Nordisk over similarity with its drug Ozempic
Indian pharma majors Sun Pharma, Dr Reddy's and Glenmark on Saturday announced the launch of their generic versions of semaglutide injection used for diabetes and weight management following the molecule behind products like Ozempic and Wegovy going off patent in India. The prices of the generic versions of semaglutide injection are considerably lower than the prices of the innovator, Novo Nordisk. Sun Pharmaceutical Industries launched its semaglutide injection under the brand names Noveltreat and Sematrinity in India, in all strengths. Noveltreat is indicated for chronic weight management in adults as an adjunct to a reduced calorie diet and increased physical activity and is available in five dose strengths -- 0.25 mg/0.5 ml, 0.5 mg/0.5 ml, 1 mg/0.5 ml, 1.7 mg/0.75 ml, and 2.4 mg/0.75 ml, Sun Pharma said in a statement. Sematrinity is indicated for treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise and is available in t
Natco Pharma Ltd. plans to sell an injection for semaglutide, the active ingredient in both Ozempic and Wegovy - with prices starting from ₹1,290
Novo Nordisk says competition in semaglutide will be driven by science and quality, not pricing, as multiple generic versions prepare to enter India after patent expiry
The Delhi High Court has upheld an order permitting Dr Reddy's Laboratories to manufacture semaglutide in India solely for export, rejecting Novo Nordisk's appeal in the ongoing patent dispute
Abbott will commercialise Extensior, a second semaglutide brand of Ozempic in India, as part of Novo Nordisk's strategy to expand access amid rising demand and looming patent expiry
Sun Pharma said it will launch generic semaglutide in India after the patent expiry in March 2026, becoming the second domestic drugmaker to secure regulatory approval for the blockbuster drug
Federal regulators have told drugmakers Novo Nordisk and Eli Lilly to remove label warnings about potential suicidal thoughts and behaviours from their blockbuster weight-loss medications. The US Food and Drug Administration on Tuesday said a comprehensive review found no increased risk related to suicide among users of the GLP-1 drugs for obesity, including Novo Nordisk's Wegovy and Saxenda and Eli Lilly's Zepbound. A preliminary review in January 2024 showed no link between the drugs and suicidal thought or actions, the FDA said. At that time, however, officials said they could not rule out that a small risk may exist. The new analysis puts those concerns to rest. Labeling for other drugs known as GLP-1 receptor agonists approved to treat diabetes carried no such warnings, the agency noted. Today's FDA action will ensure consistent messaging across the labelling for all FDA-approved GLP-1 RA medications, officials said.
The FDA had reached similar conclusion following a preliminary review in 2024, but had acknowledged at the time that it could not rule out a small risk because of limited data
The patent in question is due to lapse in March next year. The court is scheduled to take up Natco's challenge for further hearing in February