- Salix's NDA for crofelemer in HIV-associated diarrhea assigned priority review status
- Genentech's BLA for pertuzumab receives priority review status in previously untreated HER2-positive metastatic breast cancer indication
- FDA reviewers questions efficacy of NeurogesX's Qutenza pain patch in proposed new use
- Shire's Vyvanse approved for maintenance treatment in adults with ADHD
- FDA accepts Ziopharm's IND application for oral formulation of Zymafos
- 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 approves naproxen-esomeprazole combination drug
Wednesday, May 05 2010 | Comments
What's This?
The Food and Drug Administration approved a combination drug containing naproxen and esomeprazole magnesium for relieving the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients who are at risk of developing them because of nonsteroidal anti-inflammatory drug (NSAID) use.The combination therapy combines delayed-release, enteric-coated naproxen and an immediate-release version of esomeprazole. It is not recommended for use in patients aged younger than 18 years.
The approval was based in part on results from 2 Phase III trials showing that patients with certain types of arthritis who were at risk of developing gastric ulcers secondary to NSAID therapy had a significantly reduced incidence of this adverse effect if treated with the combination drug rather than with enteric-coated naproxen.
The combination therapy, which was developed by AstraZeneca Plc and Pozen Inc., will be sold under the brand name Vimovo.
Comments
Be the first to write a comment for this article!
You must be logged in to post a comment.
- 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
- Dextofisopam fails to meet primary endpoint of midstage IBS trial
- Weight loss prior to gastric bypass surgery improves outcomes in very obese patients, data indicate
- Nissen fundoplication in children with GERD reduces need for antireflux medication, researchers find
- Study supports use of adenoma detection rate as quality indicator for colonoscopy screening
- 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
- PPI use not associated with hip fractures in postmenopausal women; modest association found for other fractures, study reveals
