No Long-Term Safety Data: CDSCO Panel Denies Novo Nordisk's proposal to amend warning statement of Semaglutide Dr. Divya Colin16 March 2025 5:15 PM ISTNew Delhi: Citing that there is no real world long-term safety data for Novo Nordisk's antidiabetic drug Semaglutide tablets (3 mg, 7 mg, 14 mg), the...
Exemed Pharmaceutical Gets CDSCO Panel Nod To Manufacture Market Antidiabetic FDC Dr. Divya Colin7 March 2025 6:00 PM ISTNew Delhi: Exemed Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO Panel revises warning statement of Sanofi's antidiabetic FDC Insulin Glargine plus Lixisenatide Dr. Divya Colin13 Dec 2023 6:00 PM ISTNew Delhi: Approving the amendment in the warning statement for Sanofi's Fixed Ratio Combination of Insulin Glargine 100U/mL plus Lixisenatide 50...
Conduct Phase III CT: CDSCO Panel Tells Akum Pharmaceutical on Antidiabetic FDC Dr. Divya Colin10 Dec 2023 6:00 PM ISTNew Delhi: Rejecting the proposal for the clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Micro Labs Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug Dr. Divya Colin10 Jun 2023 5:45 PM ISTNew Delhi: Micro Lab has got the green signal from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization...
Conduct Phase III CT: CDSCO Panel Tells Sun Pharma on Liraglutide solution for injection PFP Dr. Divya Colin21 May 2023 6:00 PM ISTNew Delhi: Responding to the proposal presented by drug major Sun Pharma, for manufacturing and marketing the antidiabetic drug Liraglutide 6 mg/ml...
Eli Lilly Gets CDSCO Panel Nod to Import, Market antidiabetic drug Tirzepatide Dr. Divya Colin16 May 2023 6:00 PM ISTNew Delhi: Pharmaceutical major, Eli Lilly has got the green signal from the Subject Expert Committee (SEC) functional under Central Drug Standard...
Continue CT with 30 ongoing Indian subjects: CDSCO panel tells Novo-Nordisk on Insulin Icodec Dr. Divya Colin15 March 2023 6:00 PM ISTNew Delhi: Based on the safety data of 30 Indian subjects in the global clinical trial of Insulin Icodec, the Subject Expert Committee (SEC)...
Present revised Phase III CT protocol : CDSCO Tells Hetero Lab on Antidiabetic FDC Drug Dr. Divya Colin6 March 2023 6:00 PM ISTNew Delhi: Granting permission to conduct the bioequivalence (BE) study for antidiabetic fixed dose combination (FDC) of Sitagliptin phosphate...
CDSCO Panel Tells Synokem to conduct phase 3 CT of antidiabetic FDC drug Dr. Divya Colin5 Feb 2023 6:00 PM ISTNew Delhi: Highlighting that there is no sufficient data, no unmet need & and FDC is not approved the drug internationally, the Subject Expert...
Insulin degludec may be considered during pregnancy: CDSCO Panel tells Novo Nordisk Dr. Divya Colin2 Feb 2023 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to drug...
Submit safety data of initial 30 subjects : CDSCO Tells Novo-Nordisk On IcoSema and insulin icodec study Dr. Divya Colin28 Sept 2022 6:00 PM ISTNew Delhi: Citing to remove the 'interim analysis' from the said condition, the Subject Expert Committee (SEC) functional under Central Drug Standard...
