CDSCO Panel Grants Novartis Protocol Amendment For Ofatumumab Dr. Divya Colin31 Dec 2023 5:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Modify eGFR value as per standard guidelines: CDSCO Panel Tells Hetero Lab on Antidiabetic FDC Drug Dr. Divya Colin31 Dec 2023 5:15 PM ISTNew Delhi: Reviewing the drug major Hetero Lab's revised Phase III clinical trial protocol of fixed-dose combination antidiabetic drug Sitagliptin...
CDSCO Panel grants AstraZeneca's Protocol Amendment Proposal for Sodium zirconium cyclosilicate Dr. Divya Colin31 Dec 2023 5:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol...
Conduct BE study with innovator drug as reference product: CDSCO Panel Tells Synokem on FDC Torsemide plus Eplerenone Dr. Divya Colin30 Dec 2023 5:45 PM ISTNew Delhi: After reviewing the bioequivalence (BE) study report presented by Synokem Pharmaceutical for the fixed-dose combination Torsemide IP...
Submit PSUR data: CDSCO Panel Tells Shilpa on additional indication of Rheumatoid Arthritis drug Adalimumab Dr. Divya Colin30 Dec 2023 5:00 PM ISTNew Delhi: In response to the proposal presented by the drug major Shilpa for the extrapolation of indications for Adalimumab 100mg/mL approved in...
Submit safety, efficacy data of Indian Patients: CDSCO Panel Tells AstraZeneca on additional indication of Enhertu 100mg Dr. Divya Colin29 Dec 2023 6:15 PM ISTNew Delhi: In response to the drug major AstraZeneca's proposal for the additional indication of Trastuzumab Deruxtecan Powder Concentrate Solution...
Bayer Pharma gets CDSCO Panel nod to study Asundexian 50mg tablets Dr. Divya Colin29 Dec 2023 5:30 PM ISTNew Delhi: Bayer Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Revise BE study protocol: CDSCO Panel tells Akum Pharma on FDC of Chlorthalidone, Cilnidipine, Bisoprolol film-coated tablet Dr. Divya Colin29 Dec 2023 5:00 PM ISTNew Delhi: Citing that individual and innovators' products should be taken as a reference product in the proposed bioequivalence study protocol, the...
CDSCO Panel agrees with Bharath Serum's clarification on adverse event of Leuprolide Acetate for Injection Dr. Divya Colin27 Dec 2023 6:00 PM ISTNew Delhi: In line with the clarification presented by the pharma major Bharath Serum with respect to the adverse event of hot flashes during the...
Drug Alert: CDSCO flags 64 drug samples including Aristo's Monocef 500 Roshni Dhar27 Dec 2023 5:43 PM ISTIn its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO) has flagged 62 medicine...
Health Bulletin 27/December/2023 Roshni Dhar27 Dec 2023 5:00 PM ISTHere are the top health stories for the day:Man finds medicine in food ordered from famous Mumbai cafeA Mumbai resident, Ujwal Puri, claimed to have...
AstraZeneca Gets CDSCO Panel Nod for Enhertu 100mg for additional indication of breast cancer Dr. Divya Colin25 Dec 2023 6:00 PM ISTNew Delhi: Noting an unmet medical need in the country, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
