New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to the drug major Akums Drugs and Pharmaceutical for conducting the phase III clinical trial for the fixed drug combination (FDC) of the Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin plus Bisoprolol Fumarate IP film coated tablet.
This came after Akums Drugs and Pharmaceutical presented the proposal before the committee along with the Phase III clinical trial protocol for two strengths i.e. Bisoprolol 5mg/10mg + Dapagliflozin 10mg/10mg tablets and requested for bioequivalence (BE) study waiver. 2s 1 chloroacetyl 2 pyrrolidine carbonitrile 207557 35 5 1
The propanediol form of dapagliflozin is a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Upon administration, dapagliflozin selectively targets and inhibits SGLT2, thereby preventing the reabsorption of glucose by the kidneys.
Dapagliflozin is also indicated to either reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
Bisoprolol is a cardio selective β1-adrenergic blocking agent used to treat high blood pressure. It is considered a potent drug with a long-half life that can be used once daily to reduce the need for multiple doses of antihypertensive drugs
At the recent SEC meeting for cardiovascular held on 5th June 2024, the expert panel reviewed the proposal before the committee along with the Phase III clinical trial protocol for two strengths i.e. Bisoprolol 5mg/10mg plus Dapagliflozin 10mg/10mg tablets.
Also Read:BDR Pharmaceuticals gets CDSCO panel nod to manufacture, market anticancer drug Abiraterone Acetate Oral Suspension
Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751
World Heart Day- Revisiting Metoprolol's Contribution to Cardiology
Role of Cefepime Enmetazobactam in HAP
Responsible Use of Oral Corticosteroids in People with Comorbid Diabetes: An Indian Expert Consensus
Metformin Reduces Serum Irisin in Polycystic Ovary Syndrome: 2024 Indian Experience
New Study Reveals Key Factors Behind Medication Non-adherence: Patient Education and Distinctive...
rosuvastatin calcium World Heart Day- Revisiting Metoprolol's Contribution to Cardiology