Latest news with #Rifaximin
The Hindu
02-06-2025
- Business
- The Hindu
Zydus gets U.S. FDA tentative nod for Rifaximin tablets 550 mg
Generic drugmaker Zydus Lifesciences has received tentative approval from the U.S. Food and Drug Administration (FDA) for Rifaximin Tablets, 550 mg. The product is indicated for treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. Rifaximin tablets had annual sales of $2672.9 million in the United States, the company said citing IQVIA MAT March 2025 numbers. The product will be produced at the Group's manufacturing site at SEZ II, Ahmedabad, it said on Monday.
Business Standard
02-06-2025
- Business
- Business Standard
Zydus Lifesciences gets USFDA nod for Rifaximin tablets
Zydus Lifesciences announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for Rifaximin tablets, 550 mg, under the reference listed drug (RLD) Xifaxan tablets, 550 mg. Rifaximin tablets are indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. The tablets will be produced at the Group's manufacturing facility at SEZ II, Ahmedabad. According to IQVIA MAT 2025, Rifaximin tablets had annual sales of USD $2,672.9 million in the United States. The group now has 427 approvals and has filed 492 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in FY 2003-04. The companys consolidated net profit shed 0.96% to Rs 1,170.9 crore on 17.21% rise in revenue from operations to Rs 6290.2 crore in Q4 FY25 over Q4 FY24. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Shares of Zydus Lifesciences shed 0.53% to Rs 924.95 on the BSE.
Time of India
02-06-2025
- Business
- Time of India
Zydus gets USFDA nod for generic IBS-D treatment drug
Zydus Lifesciences on Monday said it has received approval from the US health regulator to market a drug for the treatment of irritable bowel syndrome with diarrhoea in adults. The company has received tentative approval from the US Food and Drug Administration (USFDA) for Rifaximin Tablets (550 mg), the drug manufacturing firm said in a regulatory filing. Rifaximin tablets are indicated for the treatment of irritable bowel syndrome with diarrhoea ( IBS-D ) in adults. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Access all TV channels anywhere, anytime Techno Mag Learn More Undo As per the IQVIA MAT March sales data, Rifaximin tablets had an annual sales of USD 2,672.9 million in the US. Shares of Zydus Lifesciences were trading at Rs 926.05 apiece, 0.41 per cent down from previous close, on BSE.
Business Standard
02-06-2025
- Business
- Business Standard
Zydus Lifesciences receives USFDA tentative approval for Rifaximin Tablets
Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Rifaximin Tablets, 550 mg (USRLD: Xifaxan Tablets, 550 mg). Rifaximin tablets are indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. Rifaximin tablets will be produced at the Group's manufacturing site at SEZ II, Ahmedabad. Rifaximin tablets had annual sales of USD $2672.9 mn in the United States (IQVIA MAT March 2025).
Medscape
29-05-2025
- General
- Medscape
Rifaximin Lowers Hepatic Encephalopathy Risk in Cirrhosis
Rifaximin significantly reduces the risk for hepatic encephalopathy (HE) in patients with cirrhosis, with greater effectiveness observed with longer treatment durations. METHODOLOGY: Rifaximin is recommended as an add-on therapy to lactulose for preventing the recurrence of HE, with its efficacy noted in a prior meta-analysis; however, few studies have examined its use for HE prevention. Researchers performed a systematic review and meta-analysis of randomized controlled trials involving patients with cirrhosis aged 18 years or older. Patients received either rifaximin or nonrifaximin interventions, such as nonabsorbable disaccharides, other antibiotics, L-ornithine-L-aspartate, or placebo. Primary outcomes included the incidence of HE, all-cause mortality, and adverse events. TAKEAWAY: Researchers included 12 randomized controlled trials involving 1939 patients. Compared with nonrifaximin interventions and placebo, rifaximin significantly reduced HE incidence (relative risk [RR], 0.58; P = .000), as analyzed from 10 studies. Rifaximin was significantly more effective than placebo (RR, 0.57; P = .000), but its effects were noncomparable to those of nonabsorbable disaccharides. = .000), as analyzed from 10 studies. Rifaximin was significantly more effective than placebo (RR, 0.57; = .000), but its effects were noncomparable to those of nonabsorbable disaccharides. Rifaximin treatment durations longer than 1 month were more effective in reducing HE risk (RR, 0.55; P = .000). = .000). In patients with prior HE episodes, rifaximin reduced recurrence risk by 51% compared with other interventions and placebo (five trials). Among patients receiving transjugular intrahepatic portosystemic stent shunt (TIPSS), rifaximin reduced HE risk by 30% compared with placebo ( P = .027; two trials). = .027; two trials). No significant differences were observed in all-cause mortality or adverse events between the groups, based on analyses of nine and six trials, respectively. IN PRACTICE: 'RFX [rifaximin] therapy is effective and well-tolerated in preventing HE and can be used as the first choice in the prophylaxis of HE after TIPSS,' the authors wrote. SOURCE: This study was led by Yangyang Hu, Hebei Medical University Third Hospital, Shijiazhuang, China, and published online in PLOS One . LIMITATIONS: The analysis excluded unpublished literature, potentially introducing publication and reporting bias. Only randomized controlled trials were included, and six lacked blinding, which could have affected the stability of the results. Variability in rifaximin interventions (eg, drug dosage and treatment duration) may have also affected the findings. DISCLOSURES: This study was supported by the Natural Science Foundation of Hebei Province of China. The authors declared no competing interests. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. Credit Lead image: Dubovdaniilyu/Dreamstime Medscape Medical News © 2025 WebMD, LLC Cite this: Edited by Manasi Talwadekar. Rifaximin Lowers Hepatic Encephalopathy Risk in Cirrhosis - Medscape - May 29, 2025.
