Study Safety and Efficacy of Tenecteplase 0.25 mg/kg in Acute Ischemic Stroke: CDSCO Panel Tells Boehringer Ingelheim Dr. Divya Colin10 Feb 2024 6:00 PM ISTNew Delhi: Rejecting the drug major Boehringer Ingelheim's request for waiver of the local clinical trial of Metalyse 25 mg (tenecteplase 0.25 mg/kg)...
CDSCO Panel approves Exemed Pharmaceutical to study Montelukast, Bilastine FDC Tablet Dr. Divya Colin14 Oct 2023 6:15 PM ISTNew Delhi: Based on the bioequivalence (BE) study report of fixed-dose combination pulmonary drug Montelukast Sodium plus Bilastine tablets presented...
CDSCO Panel rejects Lupin FDC of Tranexamic Acid and Mefenamic Acid Dr. Divya Colin11 July 2022 6:00 PM ISTNew Delhi: Rejecting the proposal presented by pharmaceutical major Lupin, the Subject Expert Committee (SEC) functional under Central Drug Standard...
AstraZeneca gets CDSCO nod to conduct Phase III CT of antineoplastic FDCs drug Dr. Divya Colin24 May 2022 10:45 AM ISTNew Delhi: Suggesting to increase the number of subjects in clinical trial to 34, from the proposed 24 subjects in India, the Subject Expert Committee...
Include more sites from govt hospitals: CDSCO panel tells Intas on Tofacitinib Ointment 2% CT study Dr. Divya Colin15 May 2022 12:30 PM ISTNew Delhi: Directing the pharma major Intas Pharma to include more study sites from government hospitals geographically distributed in the country,...
