- FDA reviewers support efficacy of Forest Labs' IV antimicrobial ceftaroline for treating pneumonia, complicated skin and skin structure infections
- FDA updates label for Pfizer's Tygacil to warn of increased mortality risk
- FDA approves Abbott's HBV molecular diagnostic for measuring viral load
- FDA approves new version of Allergan's Lumigan
- FDA approves Reckitt Benckiser's Suboxone sublingual film for treatment of opioid dependence
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
FDA issues complete response letters for Axanum NDA, Nexium sNDA
What's This?
The Food and Drug Administration sent 2 complete response letters to AstraZeneca Plc regarding the firm's New Drug Application (NDA) for the fixed-dose combination agent Axanum (aspirin/esomeprazole magnesium) and its supplemental NDA for Nexium (esomeprazole magnesium). The company is seeking approval of Axanum to reduce the risk of low-dose aspirin-associated gastric and/or duodenal ulcers in patients who are at risk. It is also seeking supplemental approval of Nexium to reduce the...
The Food and Drug Administration sent 2 complete response letters to AstraZeneca Plc regarding the firm's New Drug Application (NDA) for the fixed-dose combination agent Axanum (aspirin/esomeprazole magnesium) and its supplemental NDA for Nexium (esomeprazole magnesium).
The company is seeking approval of Axanum to reduce the risk of low-dose aspirin-associated gastric and/or duodenal ulcers in patients who are at risk. It is also seeking supplemental approval of Nexium to reduce the risk of low-dose aspirin-associated peptic ulcers.
Both applications, which were submitted in April 2009, were supported by results from 2 placebo-controlled trials that evaluated the safety and efficacy of Nexium in reducing the risk of gastric and duodenal ulcers in patients who were taking low-dose aspirin therapy (75 mg/day to 325 mg/d continuously during the study; continuously was defined as >=5 days per week).
AstraZeneca did not provide details about either letter, although it indicated that the FDA requested additional information. The company said it would continue discussions with the regulatory agency to determine paths forwards for both applications.
The FDA in April approved Vimovo (naproxen/esomeprazole magnesium), a fixed-dose combination agent AstraZeneca developed in conjunction with Pozen Inc. that incorporates delayed-release, enteric-coated naproxen and an immediate-release version of esomeprazole. The product is a delayed-release tablet for relieving the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and for decreasing the risk of developing gastric ulcers in patients who are at risk of developing them from using NSAIDs.
Nexium is already approved to reduce the risk of the occurrence of gastric ulcers associated with continuous NSAID therapy in patients who are at risk of developing gastric ulcers.
FDA warns of potential increase in fracture risk with PPI use, requires product label revisions 
What's This?
Using proton pump inhibitors (PPIs) for a long-term period or at high doses could increase the risk of certain fractures, according to a warning issued by the Food and Drug Administration. The agency is requiring manufacturers of drugs in this class to revise product labels to reflect this new information.The warning applies to prescription PPI products, including esomeprazole magnesium,...
NIH State-of-the-Science Conference assesses use, quality of CRC screening, makes recommendations for improvements
What's This?
The colorectal cancer (CRC) screening rate among adults aged 50 years or older in the United States has increased steadily--from 20% to 30% in 1997 to nearly 55% in 2008--but CRC screening is still both underused and misused in this country, according to a recent National Institutes of Health (NIH) State-of-the-Science Conference Statement. In February, the National Cancer Institute and the NIH
Two studies link acid suppression therapy with increased risk of C. difficile infection
What's This?
Increased levels of gastric acid suppression therapy are associated with an increased risk of Clostridium difficile infection, according to results of a recent analysis conducted among patients treated at the Beth Israel Deaconess Medical Center in Boston. In addition, results of a second study in which data from the Veterans Affairs New England Healthcare System were used extend these findings by...
Study supports use of adenoma detection rate as quality indicator for colonoscopy screening
What's This?
New data suggest that the endoscopist's adenoma detection rate is an independent predictor of a patient's colorectal cancer (CRC) risk following a screening colonoscopy, supporting the use of this variable in quality-assessment and quality-improvement programs for CRC screening.The study evaluated the association between 2 quality indicators for colonoscopy--adenoma detection rate and cecal intubation rate--and the risk of interval CRC, defined as cases of colorectal...
- Nissen fundoplication in children with GERD reduces need for antireflux medication, researchers find
- High-dose intravenous PPI regimen no better than standard-dose regimen in preventing recurrent bleeding after endoscopic hemostasis of bleeding ulcers, researchers report
- Laminar airflow ventilation during orthopedic, abdominal procedures does not prevent surgical site infections, study suggests
- Weight loss prior to gastric bypass surgery improves outcomes in very obese patients, data indicate
- Gallbladder aspiration safe but unnecessary during elective laparoscopic cholecystectomy, researchers report
- Nissen fundoplication in children with GERD reduces need for antireflux medication, researchers find
- Gallbladder aspiration safe but unnecessary during elective laparoscopic cholecystectomy, researchers report
- ACG, ACC, AHA release joint statement regarding ongoing exploration of safety of PPIs in combination with clopidogrel
- High-dose intravenous PPI regimen no better than standard-dose regimen in preventing recurrent bleeding after endoscopic hemostasis of bleeding ulcers, researchers report
- Takeda changes name of PPI Kapidex to Dexilant
