Exemed's Sitagliptin FDC Hits Roadblock as CDSCO Panel Flags No Added Safety Benefit Parthika Patel18 Jun 2025 5:53 PM ISTNew Delhi: In a setback for Exemed Pharmaceutical, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO)...
Gufic Bioscience Told To Submit More Data for Piperacillin-Tazobactam-Sodium Chloride FDC Dr. Divya Colin15 Jun 2025 9:30 AM ISTNew Delhi: In response to the proposal presented by Gufic Bioscience, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
SEC Asks Abbott to Submit More Data on Vitamin C Plus D3 FDC Chewable Tablet, Cites Lack of Justification Dr. Divya Colin14 Jun 2025 6:19 PM ISTNew Delhi: In response to the proposal presented by Abbott, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Revise Phase IV Protocol for Gliclazide-Sitagliptin FDC with Scientific Justification: SEC Tells Eris Dr. Divya Colin4 Jun 2025 3:01 PM ISTNew Delhi: Reviewing the Phase IV clinical trial of Eris Lifesciences' Fixed Dose Combination (FDC) antidiabetic drug Gliclazide plus Sitagliptin, the...
CDSCO Panel Approves BE Study for Alkem's Dapagliflozin, Pioglitazone, Metformin FDC, Seeks Revised Phase III Plan Dr. Divya Colin2 Jun 2025 1:51 PM ISTNew Delhi: Alkem Laboratories has received approval from the Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation...
DTAB Agrees to Prohibit 16 FDCs Identified as Irrational Farhat Nasim15 May 2025 9:02 PM ISTDelhi: In a major move to strengthen drug safety and rational prescribing practices, the Drugs Technical Advisory Board (DTAB) has recommended a ban...
Latest Study Finds Fixed-Dose Combination of Paracetamol, Phenylephrine, and Chlorpheniramine Maleate Effective and Safe for Common Cold in Indian Adults Dr. Garima Soni25 Dec 2024 11:34 AM ISTThe fixed-dose combination (FDC) of Paracetamol 500 mg, Phenylephrine 10 mg, and Chlorpheniramine maleate 2 mg was effective and safe for the...
DoP orders NPPA to re-evaluate ceiling price of vitamin product Thiamin 100 mg Farhat Nasim18 Oct 2024 5:53 PM ISTNew Delhi: The Department of Pharmaceuticals (DoP) has instructed the National Pharmaceutical Pricing Authority (NPPA) to re-examine and recalculate...
Goa FDA issues advisory on 156 banned FDCs Ruchika Sharma19 Sept 2024 3:28 PM ISTPanaji: Following a recent ban on 156 fixed-dose combinations by the Central Government, the Directorate of Food and Drugs...
Novel HIV drug formulation could improve treatment outcomes for children globally Isra Zaman4 Aug 2023 9:30 AM ISTResearchers at the University of Colorado Anschutz Medical Campus have helped confirm the dosing, safety and effectiveness of a drug formulation...
Novel triple-drug FDC superior to dual combination in type 2 diabetes patients poorly controlled with metformin Medha Baranwal2 Jun 2023 11:30 AM ISTIndia: A recent study has shown a triple-drug fixed-dose combination (FDC) of sitagliptin + dapagliflozin + metformin ER to be superior to dual...
Interim relief to Novartis: Delhi HC reinstates Entresto (Sacubitril-Valsartan) patent in India Farhat Nasim27 Jan 2023 6:26 PM ISTDelhi: In an interim relief to Swiss pharma major Novartis, the Delhi High Court has reinstated Entresto (sacubitril/valsartan) patent in India amid...
