In a sort of good news/bad news move, the FDA is allowing Merck to expand marketing of the diabetes drug Januvia--but it's also expanding the warnings on Januvia's label.
Now, Merck can sell the drug for use in combo with other diabetes meds, rather than as a supplement to diet and exercise alone. The new label will highlight warnings of hypersensitivity reactions, including the rare-but-deadly Stevens-Johnson syndrome.
- take a look at Merck's release [1]
- read the report [2] from the Houston Chronicle
Related Articles:
ADA meeting sees new data on diabetes drugs. Report [3]
FDA expected to approve Januvia soon. Report [4]
Links:
[1] http://www.fiercebiotech.com/press-releases/press-release-mercks-januvia-wins-new-uses-risks-outlined
[2] http://www.chron.com/disp/story.mpl/ap/fn/5222516.html
[3] http://www.fiercebiotech.com/story/ada-meeting-sees-new-data-on-diabetes-drugs/2006-06-12
[4] http://www.fiercebiotech.com/story/fda-expected-to-approve-januvia-soon/2006-10-16
[5] http://www.fiercebiotech.com/tags/merck
[6] http://www.fiercebiotech.com/tags/januvia