Lupin’s Vilfuro-G blends fluticasone furoate, vilanterol and glycopyrronium bromide and is the world’s first FDC to manage and treat moderate to severe COPD on a long-term basis.
The company is offering the drug in a single-strength fixed dose, with a recommended dosage of once a day.
The product is expected to benefit 37 million people with COPD, a condition that is one of India’s primary causes of death and disability.
Lupin India region formulations president Rajeev Sibal stated: “As the global prevalence of COPD continues to surge, India bears a significant 18% of this disease burden.
“With our extensive respiratory portfolio and the approval of Vilfuro-G, we take immense pride in offering healthcare professionals and patients innovative treatment solutions.”
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The US Food and Drug Administration (FDA) has also granted tentative approval for Lupin’s abbreviated new drug application for canagliflozin tablets.
The approval is for 100mg and 300mg tablets to be sold as a generic version of Janssen Pharmaceuticals’ 100mg and 300mg Invokana tablets.
Canagliflozin, a sodium-glucose co-transporter 2 inhibitor, is intended for use as an adjunct to diet and exercise to enhance glycaemic control in adults with type 2 diabetes mellitus. Sales of the tablets generate $561m in annual sales in the US.
The drug minimises major adverse cardiovascular events risk in those with type 2 diabetes mellitus and established cardiovascular disease.
It also helps reduce the risk of end-stage kidney disease, the doubling of serum creatinine, cardiovascular death and hospitalisation for heart failure in adults struggling with type 2 diabetes mellitus and diabetic nephropathy with albuminuria.