Pozen Submits Human Lymphocyte Study Findings to FDA
Posted on: Wednesday, 16 January 2008, 09:00 CST
Pozen has submitted the findings from the short-term human volunteer study of the genotoxic potential of Treximet to the FDA.
The results of this study indicate that no chromosomal aberrations were induced in peripheral blood lymphocytes when Treximet was administered to volunteers for seven days. The submission of this study report is in addition to the response made to the FDA in October 2007 which provided clarifying information on the Chinese Hamster Ovary (CHO) assay.
The company has also received notification from the FDA that it has tentatively accepted the trade name Treximet (formerly known as Trexima), subject to final NDA approval, for the proposed product candidate combining sumatriptan 85mg, formulated with RT Technology and naproxen sodium 500mg in a single tablet.
Treximet, which is currently under review by the FDA for the acute treatment of migraine, is being developed by Pozen under an alliance with GlaxoSmithKline.
Source: Datamonitor
Related Articles
- FDA to Study Images' Impact in Drug Ads
- FDA Requests Study for Neurocrine's Drug
- FDA: More Study Needed on Birth Control Patch Risk
- FDA: More study needed on J&J birth control patch
- DOBI Medical International Releases ComfortScan(R) Version 2.0 Software Suite; Updates FDA PMA Study Progress
- Quigley Pharma Issued An Investigational New Animal Drug (INAD) Number By The FDA To Study Its Anti-Viral Compound For Avian Flu In Pigs; Pigs May Serve As Intermediate Hosts for Virus & Source of Transmission to Humans
- Quigley Pharma is Issued Three Investigational New Animal Drug (INAD) Numbers By the FDA To Study Its Anti-Viral Compound On Avian Flu
- InSightec Announces Enrollment of African American Women in FDA PostMarketing Study
- FDA to Study Adult Antidepressant Effects
- FDA Halts Study on Dietary Supplements
 |
 |
User Comments (0)
RSS Feeds