Sun Pharmaceutical Industry gets CDSCO Panel nod to study Fexuprazan HCL tablet for erosive esophagitis Dr. Divya Colin11 Aug 2024 6:00 PM ISTNew Delhi: Responding to the proposal presented by the Sun Pharmaceutical Industry to manufacture and market the Fexuprazan Hydrochloride tablet, the...
Dr. Reddy's Lab gets CDSCO Panel nod to study Semeglutide injection Dr. Divya Colin10 Aug 2024 6:00 PM ISTNew Delhi: In line with the bioequivalence study report of Semaglutide Injection 2mg/1.5ml (1.34mg/ml) and 4mg/3ml (1.34mg/ml) (Synthetic Origin)...
Pfizer Gets CDSCO Panel Nod for Active PMS Study of FDC Levonorgestrel Plus Ethinyloestradiol Tablets Dr. Divya Colin9 Aug 2024 6:00 PM ISTNew Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO announces waiver of local clinical trials in 5 drug categories that are approved in developed markets Ruchika Sharma8 Aug 2024 2:21 PM ISTNew Delhi: In a significant move to improve the accessibility of new drugs in India, the Central Drugs Standard Control Organization (CDSCO) has...
Pfizer gets CDSCO Panel nod to study Somatrogon Dr. Divya Colin7 Aug 2024 6:00 PM ISTNew Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Drugs not yet marketed in India, Submit PSUR Data: CDSCO Panel Tells Novo Nordisk on Semaglutide injection Dr. Divya Colin6 Aug 2024 6:00 PM ISTNew Delhi: Noting that proposed drug products Semaglutide Injection 0.25mg/0.5mg/1mg/1.7mg/2.4mg (Wegovy) and Semaglutide Injection...
Justify proposed dose and rationality: CDSCO Panel Tells Lupin on FDC Sacubitril plus Valsartan Dr. Divya Colin5 Aug 2024 6:00 PM ISTNew Delhi: In response to the justification presented by the drug major Lupin on the rationality of the fixed-dose combination (FDC) cardiovascular...
Submit clinical study data conducted in adults: CDSCO Panel Tells Sanofi on atopic dermatitis drug Dr. Divya Colin4 Aug 2024 6:00 PM ISTNew Delhi: Responding to the protocol amendment proposal for Amlitelimab study, the Subject Expert Committee (SEC) functional under the Central Drug...
Submit CT data of Liraglutide pre-filled pen for type 2 DM: CDSCO Panel Tells Biocon Pharma Dr. Divya Colin3 Aug 2024 6:00 PM ISTNew Delhi: Citing that the approved indication for BIOLIDE synthetic Liraglutide 6mg/ml solution for injection in a pre-filled pen in UK-MHRA is for...
Akums Drugs and Pharma Gets CDSCO Panel Nod to study Aceclofenac plus Drotaverine Hydrochloride tablet Dr. Divya Colin2 Aug 2024 6:00 PM ISTNew Delhi: The drug major Akums Drugs and Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug...
Eli Lilly Gets CDSCO Panel Nod to Study Retatrutide Dr. Divya Colin1 Aug 2024 6:00 PM ISTNew Delhi: Pharmaceutical major Eli Lilly has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Insufficient CT data in female population: CDSCO Panel tells Alkem Laboratories on Relugolix Tablets Dr. Divya Colin31 July 2024 6:00 PM ISTNew Delhi: Noting insufficient clinical trial data in the female population for applied indication, the Subject Expert Committee (SEC) functional...
