Akums Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug Dr. Divya Colin13 Feb 2024 6:00 PM ISTNew Delhi: The drug major Akum Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
CDSCO Panel rejects Synokem proposal for FDC of Mecobalamin, Nortriptyline, Pregabalin Dr. Divya Colin12 Feb 2024 6:00 PM ISTNew Delhi: Citing that the proposed fixed-dose combination (FDC) of Mecobalamin IP 1500mcg plus Nortriptyline Hydrochloride IP Eq. to Nortriptyline...
Modify Clinical Study Protocol: CDSCO Panel Tells Roche On Multiple Sclerosis Drug Ocrelizumab Dr. Divya Colin11 Feb 2024 6:00 PM ISTNew Delhi: In response to the proposal presented by drug major Roche to conduct the Phase IV clinical trial for the drug product Ocrelizumab 300 mg...
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)...
Submit Animal Toxicity Study Report: CDSCO Panel Tells Lupin on Parkinsonism FDC drug Dr. Divya Colin9 Feb 2024 6:00 PM ISTNew Delhi: Noting that the proposed dose is higher than the approved dose, the Subject Expert Committee (SEC) functional under the Central Drug...
Conduct India-specific Trial: CDSCO Panel Tells Roche on Satralizumab to Treat neuromyelitisoptica spectrum disorders Dr. Divya Colin8 Feb 2024 6:00 PM ISTNew Delhi: With an aim to establish the safety and efficacy of the Monoclonal Antibody Satralizumab in Indian patients, the Subject Expert Committee...
NPPA fixes price for various FDCs having Sitagliptin, Linagliptin Ruchika Sharma7 Feb 2024 6:00 PM ISTNew Delhi: The National Pharmaceutical Pricing Authority (NPPA) has announced that it has fixed retail prices of 39 formulations under the Drugs...
MSD NOT involved in Poonam Pandey fake death stunt: Makers of Gardasil clarify, cut ties with agency involved in controversy Farhat Nasim7 Feb 2024 4:50 PM ISTNew Delhi: MSD, the Indian affiliate of the US pharmaceutical giant Merck has clarified that it is not associated with actor and model Poonam Pandey’s...
Synokem gets CDSCO Panel nod to study FDC Torsemide plus Eplerenone film coated tablet Dr. Divya Colin6 Feb 2024 6:00 PM ISTNew Delhi: Considering the bioequivalence (BE) report of the fixed-dose combination (FDC) Torsemide IP 10mg/ 20mg plus Eplerenone IP 25mg/25mg...
CDSCO Panel grants Intas Package Insert update for Pegfilgrastim solution for injection 6mg/0.6mL vial and PFS Dr. Divya Colin5 Feb 2024 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Center Drug Standard Control Organisation (CDSCO) has approved drug major Intas...
Windlass Biotech gets CDSCO Panel Nod To Manufacture, Market Ezetimibe plus Atorvastatin Calcium tablet Dr. Divya Colin4 Feb 2024 6:00 PM ISTNew Delhi: In response to the proposal presented by the drug major Windlas Biotech, the Subject Expert Committee (SEC) functional under the Central...
Add geographically distributed Govt sites: CDSCO Panel tells Dr Reddy's on antirheumatic drug Abatacept study Dr. Divya Colin3 Feb 2024 6:00 PM ISTNew Delhi: The drug major Dr Redyy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
