Cipla gets USFDA nod for generic acid reflux drug

The company has received final approval for its abbreviated new drug application (ANDA) for Esomeprazole for oral suspension in the strengths of 10mg, 20mg and 40mg from the United States Food and Drug Administration (USFDA), Cipla said in a statement.
Source: The Economic Times Healthcare and Biotech News - Category: Pharmaceuticals Source Type: news

Related Links:

ConclusionRobotically assisted Heller myotomy and POEM are safe and efficacious treatments for achalasia with lower rates of technical complications compared to laparoscopic Heller myotomy. With the advancements in endoscopic instruments and robotic surgery, POEM and robotically assisted Heller myotomy should be considered in the treatment of achalasia and esophageal dysmotility disorders.
Source: Surgical Endoscopy - Category: Surgery Source Type: research
ConclusionsThis is the first study to demonstrate a procedural factor that increases post-POEM esophagitis. Gastric myotomy  >  2.5 cm results in increased rates of moderate esophagitis without improving clinical efficacy. Some patients developed esophagitis in a delayed fashion, emphasizing the importance of ongoing surveillance. We also believe that preserving the gastric sling fibers may help to reduce reflux rates. T he double-scope method may help to control myotomy length (2.0–2.5 cm) and direction (lesser curve to avoid the gastric sling) to help maximize clinical efficacy while mini...
Source: Surgical Endoscopy - Category: Surgery Source Type: research
ConclusionsReflux is common after POEM. A majority of patients with a positive BRAVO study are asymptomatic, which is concerning. Objective follow-up is of paramount importance with upper endoscopy and ambulatory pH monitoring being the gold standard. Elevated preoperative Eckardt score and esophagitis are associated with post-POEM reflux. This population warrants close surveillance.
Source: Surgical Endoscopy - Category: Surgery Source Type: research
AbstractObjectivesDiagnostic workup after febrile urinary tract infections (fUTIs) in children remains a matter of debate. The authors aimed to evaluate multiple parameters in order to design a predictive tool enabling a targeted indication of voiding cystourethrography (VCUG).MethodsRecords of 383 consecutive children who underwent a VCUG as well as a dimercaptosuccinic-acid (DMSA) scan after febrile urinary tract infections (fUTIs) at a single institution between 04/2009 and 06/2014 were reviewed. Twenty parameters were recorded. After regression analysis, 6 parameters were incorporated into a computational tool aiming a...
Source: Indian Journal of Pediatrics - Category: Pediatrics Source Type: research
Conditions:   Gastroesophageal Reflux;   Sleeve Gastrectomy;   Bariatric Surgery Complication Intervention:   Device: EndoFLIP measurement Sponsor:   Mayo Clinic Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
In the paper by Angrisani et al, the authors tackle an important question, namely; what are the long term outcomes regarding gastroesophageal reflux disease (GERD) in patients undergoing sleeve gastrectomy (SG) [1]? Many surgeons consider GERD to be the Achilles heel of the SG, and it is one of the main reasons for conversion of the SG to other procedures such as the gastric bypass [2]. The last International Consensus Conference on SG demonstrated that over 50% of surgeons considered GERD to be a relative contrindication to the SG, and also that hiatal hernias (HH) should be repaired when encountered [3].
Source: Surgery for Obesity and Related Diseases - Category: Surgery Authors: Source Type: research
CONCLUSION: In this population-based study in Denmark, the reoperation rate 15 years after antireflux surgery was 12·8 per cent. Reoperations were associated with more complications. PMID: 32484246 [PubMed - as supplied by publisher]
Source: The British Journal of Surgery - Category: Surgery Authors: Tags: Br J Surg Source Type: research
Wide area transepithelial sample biopsy with three-dimensional computer-assisted analysis (WATS, CDx Diagnostics, Suffern, NY) uses brush sampling to evaluate histologic features of a wide area of mucosa. WATS ’ yield for intestinal metaplasia (IM) in a diagnostic or screening examination for Barrett’s esophagus (BE) with endoscopic evidence of columnar epithelium in the esophagus is incompletely described.
Source: Gastrointestinal Endoscopy - Category: Gastroenterology Authors: Tags: Poster abstracts Source Type: research
Transoral Incisionless Fundoplication (TIF) is a minimally invasive endoscopic technique proven to be safe and effective for treating Gastroesophageal Reflux Disease (GERD) in selected patients. The learning curve of this technique has not been studied.
Source: Gastrointestinal Endoscopy - Category: Gastroenterology Authors: Tags: Poster abstracts Source Type: research
Sleeve gastrectomy (SG) is associated with significant rates of de novo and worsened gastroesophageal reflux disease (GERD) and thus, Roux-en-Y gastric bypass is typically the preferred bariatric surgery in patients with symptomatic GERD. Patients with silent reflux symptoms, may however still undergo SG, which could put patients at risk for complications such as Barrett ’s esophagus (BE). We aimed to determine the incidence rate of BE in patients who have undergone SG and to assess the use of EGD pre- and post-surgery using a large database.
Source: Gastrointestinal Endoscopy - Category: Gastroenterology Authors: Tags: Poster abstracts Source Type: research
More News: Acid Reflux | Biotechnology | Esomeprazole | Food and Drug Administration (FDA) | Gastroesophageal Reflux Disease | GERD | New Drug Applications | Nexium | Pharmaceuticals | USA Health