Sun Pharma Fails to Secure CDSCO Nod for BE, Phase III Waiver on Sitagliptin, Glimepiride, Metformin FDC Susmita Roy7 Sept 2025 3:30 PM ISTNew Delhi: Citing the absence of supporting data for the proposed strength of the fixed-dose combination (FDC) of Sitagliptin phosphate monohydrate,...
Hetero Labs' Acarbose-Sitagliptin-Metformin FDC Rejected by CDSCO Panel Over GI Risk Dr. Divya Colin30 Jun 2025 5:45 PM ISTNew Delhi: In a setback to Hetero Labs Limited, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation...
Laurus Labs Asked to Submit Justification, Data for Pediatric Darunavir-Ritonavir FDC Proposal Farhat Nasim23 Jun 2025 3:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) on Antimicrobial & Antiviral under the Central Drugs Standard Control Organisation (CDSCO) has asked...
Sun Pharma Gets Relief on Packaging Norms for Pantoprazole-Levosulpiride FDC Parthika Patel21 Jun 2025 4:18 PM ISTNew Delhi: In a regulatory relief to the company, the Subject Expert Committee (SEC) under the Gastroenterology and Hepatology division of the Central...
Zydus Gets CDSCO Panel Nod to Conduct Phase IV Trial for Indacaterol-Budesonide FDC Inhalation Dr. Divya Colin20 Jun 2025 11:45 PM ISTNew Delhi: In response to the proposal presented by Zydus Healthcare, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
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)...
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...
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...
DCGI Told to Act Against Unapproved Antibiotic FDCs Farhat Nasim14 May 2025 7:48 PM ISTNew Delhi: The Drugs Technical Advisory Board (DTAB), India's apex drug advisory body, has taken a firm stance on curbing the irrational use of...
FDC recalls more than 60000 bottles of glaucoma medication in US Ruchika Sharma10 May 2025 12:30 PM ISTMumbai: Mumbai-headquartered drug firm FDC Ltd is recalling 60,428 bottles of Timolol Maleate Ophthalmic Solution in the US market over...
4 Diabetes Medication FDCs including Glimipride Metformin Strength banned by Health Ministry Farhat Nasim18 April 2025 6:13 PM ISTDelhi: The Central Drugs Standard Control Organization (CDSCO) has banned the manufacture, sale, and distribution of certain widely used strengths of...
