Glenmark receives approval for combination of Remogliflozin Etabonate and Metformin Hydrochloride used for treating type 2 diabetes in India
Mumbai : Pharmaceuticals major Glenmark Pharmaceuticals Ltd. (Glenmark), on Monday announced that it has received regulatory approval to market a combination of its novel, patent protected and globally‐researched sodium glucose co‐transporter‐2 (SGLT2) inhibitor Remogliflozin etabonate (Remogliflozin) and Metformin Hydrochloride (Metformin) film coated tablets in India. The drug is indicated in the treatment of type‐2 diabetes mellitus in adults. Glenmark will commercialize the product under the brand names ‘Remo‐M’ and Remozen‐M’.
Earlier in April 2019, Glenmark received regulatory approval for Remogliflozin etabonate 100 mg tablets, twice daily, after successfully completing Phase‐3 clinical trials in which Remogliflozin demonstrated good efficacy and safety profile in a head‐to‐head comparison against Dapagliflozin. With this approval Glenmark became the first company in the world to launch the novel SGLT2 inhibitor Remogliflozin with India being the first country to get access to this innovative drug. Glenmark subsequently launched Remogliflozin in India under the brand names ‘Remo’ and ‘Remozen’.
Glenmark has now received regulatory approval for a combination of Remogliflozin and Metformin film-coated tablets. The approved dosage strengths are 100 mg of Remogliflozin combined with either 500 mg or 1,000 mg of Metformin. This combination is indicated as an adjunct to diet and exercise to improve glycemic control in type‐2 diabetes mellitus patients(for full indication, it is advisable to refer the package insert).