- Idenix's hepatitis program for two investigational agents placed on clinical hold by FDA, shares plummet
- FDA to allow continued availability of Shire's ProAmatine, generic formulations, reversing earlier decision to withdraw products
- FDA advisory panel recommends approval of Forest Labs' IV antimicrobial ceftaroline for treating pneumonia, complicated skin and skin structure infections
- FDA approves expanded indications for Merck's Saphris antipsychotic
- FDA reviewers support efficacy of Forest Labs' IV antimicrobial ceftaroline for treating pneumonia, complicated skin and skin structure infections
- 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 refuses to file NDA for Adventrx's investigational NSCLC treatment
Friday, March 12 2010 | Comments
What's This?
Adventrx Pharmaceuticals Inc. said the Food and Drug Administration refused to file the firm's New Drug Application (NDA) for ANX-530, an emulsion formulation of vinorelbine tartrate, for the treatment of advanced non-small cell lung cancer (NSCLC).The FDA sent Adventrx a letter stating that the submission contained data related to the intended commercial manufacturing site that was insufficient to support a commercially viable expiration dating period. Adventrx said this was the FDA's only reason for refusing to file the NDA, which was submitted in December.
"We believed, following discussions with the FDA at a pre-NDA meeting, the stability data package included in our initial submission supported both NDA acceptance and appropriate expiration dating. However, we now expect [the] FDA will require additional site-specific stability data to accept our application," said Brian Culley, chief executive officer of Adventrx.
The company plans to meet with U.S. regulators as soon as possible to discuss its response regarding the NDA.
Comments
Be the first to write a comment for this article!
You must be logged in to post a comment.
- White blood cell count in presence of elevated ESR, CRP level predicts infection status in patients undergoing total hip arthroplasty, researchers report
- AISRS useful in measuring methylphenidate therapy for adults with ADHD
- Adalimumab improves peripheral arthritis, enthesitis, axial signs, symptoms of AS in patients with long-standing disease treated in real-life practice, researchers report
- High levels of hemoglobin A1C appear to increase risk of complications following CABG
- Radiotherapy, chemotherapy increase risks of second malignancy, cardiovascular disease similar to smoking in patients with testicular cancer, researchers report
- School-based nutrition, exercise intervention program may not maintain BMI decreases through 10 months in overweight students, data indicate
- Careful discharge planning, follow-up vital for high-risk neonates facing hospital discharge, updated AAP guidelines state
- MTA Cooperative Group uses 8-year MTA follow-up data to assess long-term outcomes in children with ADHD
- Radiotherapy, chemotherapy increase risks of second malignancy, cardiovascular disease similar to smoking in patients with testicular cancer, researchers report
- Lipid-modifying drugs may decrease all-cause, cardiovascular-specific mortality in patients on peritoneal dialysis, study data suggest
