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CDSCO panel agrees with Sun Pharmaceutical's Phase IV Trial Results of Cephalexin plus Clavulanate Potassium Tablets
![CDSCO panel agrees with Sun Pharmaceuticals Phase IV Trial Results of Cephalexin plus Clavulanate Potassium Tablets CDSCO panel agrees with Sun Pharmaceuticals Phase IV Trial Results of Cephalexin plus Clavulanate Potassium Tablets](https://medicaldialogues.in/h-upload/2024/01/30/750x450_231245-untitled-design-1.webp)
Sun pharma 50
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has agreed to the Phase IV clinical trial report of the fixed-dose combination (FDC) antimicrobial drug Cephalexin extended released (ER) 375mg/750mg plus Clavulanate Potassium 125mg/125mg tablets presented by Sun Pharmaceuticals.
Phase IV clinical trial is a type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market.
Cephalexin is the first of the first-generation cephalosporins. This antibiotic contains a beta-lactam and a dihydrothiazide. Cephalexin is used to treat a number of susceptible bacterial infections through inhibition of cell wall synthesis. Cephalexin was approved by the FDA on 4 January 1971.
Cephalexin is indicated for the treatment of certain infections caused by susceptible bacteria. These infections include respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infection
Clavulanic acid is a beta-lactamase inhibitor used to enhance the effectiveness of beta-lactam antibiotics. Clavulanic acid is derived from the organism Streptomyces clavuligerus.
Clavulanic acid contains a beta-lactam ring in its structure that binds in an irreversible fashion to beta-lactamases, preventing them from inactivating certain beta-lactam antibiotics, with efficacy in treating susceptible gram-positive and gram-negative infections.
Doctor of Pharmacy
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