No Safety Data On Indian Populations: CDSCO panel tells Alkem over Cefixime Oral Suspension Dr. Divya Colin11 Feb 2023 12:30 PM GMTNew Delhi: Rejecting the drug major Alkem's proposal for manufacturing and marketing the antibiotic drug Cefixime Oral Suspension IP 200mg/ml...
Eris Lifescience gets CDSCO panel nod to study FDC of Metoprolol Succinate, Dapagliflozin Dr. Divya Colin21 Jan 2023 11:00 AM GMTNew Delhi: Directing to present bioequivalence (BE) study results in the Subject Expert Committee (SEC) before initiating the Phase III clinical...
Glenmark gets CDSCO Panel nod to Study FDC Of Bilastine, Dextromethorphan ,Phenylephrine Syrup Dr. Divya Colin12 Dec 2022 12:30 PM GMTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to drug...
Rationale to conduct trial of Tozorakimab is not adequate: CDSCO tells AstraZeneca Dr. Divya Colin11 Dec 2022 12:30 PM GMTNew Delhi: Citing that the rationale for conduct of the proposed trial of COPD (Chronic obstructive pulmonary disease) drug Tozorakimab is not...
Submit Safety Data with Subgroup Analysis of CT: CDSCO Panel Tells Akum Pharma on Tofacitinib Oral Solution Dr. Divya Colin26 Nov 2022 12:15 PM GMTNew Delhi: Regarding the proposal for manufacturing and marketing of anti-rheumatic drug Tofacitinib Oral Solution 1mg/ml, the Subject Expert...
MSN Laboratories gets CDSCO panel nod to manufacture, market Icatibant Injection Dr. Divya Colin18 Nov 2022 12:30 PM GMTNew Delhi: Directing that the drug should be sold by retail under the prescription of the designated medical specialist only, the Subject Expert...
Sanofi gets CDSCO panel nod to market Biphasic Insulin Aspart Injection Dr. Divya Colin8 Nov 2022 12:30 PM GMTNew Delhi: With a condition of conducting a phase IV study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Dr. Reddy proposal to market antidiabetic FDC of Imeglimin and Vildagliptin rejected by CDSCO Panel Dr. Divya Colin2 Nov 2022 12:30 PM GMTNew Delhi: Noting that the clinical experience with the drug Imeglimin is very limited, the Subject Expert Committee (SEC) functional under the...
Zydus Naftifine HCL 2% Cream Gets CDSCO Panel nod to treat superficial fungal infection of skin Dr. Divya Colin1 Nov 2022 12:30 PM GMTNew Delhi: Pharmaceutical major, Zydus has got green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO Panel Tells MSN Lab to Produce Raw Data on Icatibant Injection Dr. Divya Colin24 Oct 2022 7:45 AM GMTNew Delhi: In response to drug maker MSN Laboratories' justification for bioavailability (BE) study waiver for Icatibant Injection 30mg/3ml (10mg/ml)...
AstraZeneca Gets CDSCO panel nod to Import, Market Anti-Diabetic Dapagliflozin for Additional Indication Dr. Divya Colin23 Oct 2022 6:00 AM GMTNew Delhi: Pharmaceutical major AstraZeneca has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard...
SII gets CDSCO panel nod to study Pneumococcal Polysaccharide Conjugate Vaccine,Adsorbed,10-Valent Dr. Divya Colin21 Oct 2022 12:30 PM GMTNew Delhi: Serum Institute of India has got a go-ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control...
