Conduct Randomized Control Phase III CT in Indian Population: CDSCO Panel Tells Pfizer on Rimegepant Dr. Divya Colin15 March 2024 6:00 PM ISTNew Delhi: Rejecting the proposal for local Phase III clinical trial waivers, the Subject Expert Committee (SEC) functional under the Central Drug...
Wockhardt gets CDSCO Panel nod to study Biphasic insulin aspart Dr. Divya Colin15 March 2024 5:30 PM ISTNew Delhi: Reviewing the protocol presented by the drug major Wockhardt, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Abbott gets CDSCO Panel Nod To study FDC Dydrogesterone plus Estradiol Dr. Divya Colin14 March 2024 6:00 PM ISTNew Delhi: The drug major Abbott has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO panel Rejects Akum Pharma's FDC Bempedoic acid plus Atorvastatin Calcium plus Ezetimibe Dr. Divya Colin11 March 2024 6:00 PM ISTNew Delhi: Reviewing the justification presented by the drug major Akum Pharmaceutical with respect to the triple-drug combination of Bempedoic acid...
Conduct Phase III CT of Ursodeoxycholic acid for Non-alcoholic fatty liver disease: CDSCO Panael Tell Abbott Dr. Divya Colin10 March 2024 6:00 PM ISTNew Delhi: In response to the proposal presented by the drug major Abbott for the additional indication for the already marketed formulation...
Zydus Healthcare gets CDSCO Panel Nod To study FDC Empagliflozin plus Metoprolol Succinate Dr. Divya Colin10 March 2024 5:45 PM ISTNew Delhi: The drug major Zydus Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Synokem gets CDSCO Panel Nod To Study FDC Dapagliflozin plus Sacubitril plus Valsartan Dr. Divya Colin10 March 2024 5:30 PM ISTNew Delhi: The drug major Synokem Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
AstraZeneca gets CDSCO Panel Nod To Import, Market Sodium Zirconium Cyclosilicate Powder for Oral Suspension Dr. Divya Colin9 March 2024 6:00 PM ISTNew Delhi: Noting an unmet medical need, the Subject ExperCommittee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has...
Justify bioequivalent data: CDSCO Panel Tells Sun Pharma on Mirabegron Extended-release Tablets Dr. Divya Colin8 March 2024 6:00 PM ISTNew Delhi: After reviewing the bioequivalence (BE) report of Mirabegron extended-release Tablets 50 mg presented by drug major Sun Pharma, the Subject...
AstraZeneca gets CDSCO Panel Nod To update Prescribing Information of Antidiabetic FDC Dr. Divya Colin7 March 2024 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to...
CDSCO Panel rejects Torrent proposal To Waive BE Study of FDC Gabapentin plus Duloxetine Dr. Divya Colin6 March 2024 6:00 PM ISTNew Delhi: Rejecting the proposal for the bioequivalence (BE) study waiver, the Subject Expert Committee (SEC) functional under the Central Drug...
Submit Post Marketing Safety Data of Indians: CDSCO Panel Tells Novo Nordisk on Semaglutide Warning Statement Dr. Divya Colin5 March 2024 6:00 PM ISTNew Delhi: In response to the proposal presented by the drug major Novo Nordisk for the amendment in the warning statement for the antidiabetic drug...
