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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 .
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
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.