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Zydus Lifesciences on Wednesday has received approval from the US health regulator to market a generic diabetes drug in the US market. The company has received tentative approval from the US Food and Drug Administration (USFDA) for Dapagliflozin Tablets in strengths of 5 mg and 10 mg, the drug firm said in a statement. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. The company said the tablets will be manufactured at its formulation manufacturing facility at SEZ, Ahmedabad. As per the industry estimates, Dapagliflozin tablets had annual sales of USD 10,486.9 million in the US. Zydus shares on Wednesday ended 0.23 per cent up at Rs 905 apiece on BSE.
Biotech firm Biocon on Tuesday said it has received approval from the government authorities for a generic diabetes medication. The company has received approval for its Liraglutide drug substance and its wholly-owned subsidiary Biocon Pharma has received approval for its Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge), from the Drugs Controller General of India (CDSCO). The approval is for the generic version of Victoza, indicated for the treatment of insufficiently controlled Type 2 Diabetes Mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise, the company said in a regulatory filing. "The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes," Biocon CEO and MD Siddharth Mittal said. India has one of the highest number of people with diabetes globally, with ...