metformin hydrochloride ER/glimepiride / Generic mfg. - LARVOL DELTA

4 Diabetes Medication FDCs Including Glimipride Metformin Strength Banned By Health Ministry (Medical Dialogues) - "The Central Drugs Standard Control Organization (CDSCO) has banned the manufacture, sale, and distribution of certain widely used strengths of fixed dose combinations (FDCs) in the anti-diabetic segment. These FDCs, including popular oral therapies combining metformin, glimepiride, voglibose, and dapagliflozin, were previously licensed by various State Licensing Authorities (SLAs) without due approval or evaluation by the Drugs Controller General of India (DCGI)....Among the Antidiabetic agents, strengths of FDCs listed as either cancelled or voluntarily surrendered following show-cause notices are: Metformin Hydrochloride IP 500mg (as extended release form) + Glimepiride IP 3mg + Dapagliflozin Propanediol Monohydrate IP eq. to Dapagliflozin 10mg film coated bilayered tablets; Glimepiride IP 1mg & Metformin HCL IP 500mg Tablet; Glimepiride IP 2mg, Metformin Hydrochloride IP (As Sustained Release form) 500mg and Voglibose IP 0.3mg Tablet; Metformin Hydrochloride..."

Commercial • Diabetes

Fixed dose combination of dapagliflozin, glimepiride and extended-release metformin tablets in patients with type 2 diabetes poorly controlled by metformin and glimepiride: A phase III, open label, randomized clinical study in India. (PubMed, Diabetes Obes Metab) - "This study demonstrated that the FDC of DAPA + GLIM + MET ER tablets once daily was significantly better than dual FDC in achieving glycaemic control in patients with poorly controlled T2DM. Both treatments were well-tolerated."

Journal • P3 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Granules India gets USFDA approval of Metformin Hydrochloride ER Tablets (ExpressPharma) - "Granules India announced that the US Food & Drug Administration (US FDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg, generic equivalent of Glumetza ER Tablets, 500 mg and 1000 mg, of Bausch Health US....indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus."

ANDA • Diabetes