| Up
2006P-0371:
Immediately Add a Black Box Warning Regarding the Risks of Tendinopathy
and Tendon Rupture to the Product Labels of all Fluoroquinolone
Antibiotics Presently on the Market in the United States
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Document #
|
| Received Date
|
| Filed
Date
|
| Submitter Code
|
| Submitter
|
| FR
Date
|
| FR
Page
|
| Comment Date
|
| Files
|
| Remarks
|
|
|
|
|
|
| |
CP1 |
|
08/29/2006
|
|
09/08/2006
|
|
Consumer Group
|
|
Public Citizen's
Health Research Group |
|
|
|
|
|
|
|
pdf |
|
|
|
| |
Signature: |
|
Jay Parkinson, MD, MPH and
Sidney |
|
| |
| |
ACK1 |
|
09/08/2006
|
|
09/08/2006
|
|
Federal Government |
|
FDA/DDM to
Public Citizen's Health Research Group |
|
|
|
|
|
|
|
pdf |
|
|
|
| |
Signature: |
|
Lyle D. Jaffe |
|
|
| |
EC1 |
|
10/10/2006
|
|
10/08/2006
|
|
Individual Consumer
|
|
Mr. Dave Lowe
|
|
|
|
|
|
|
|
htm
Attachment
|
|
|
|
Top | Up
Page last updated
January 5, 2007
kk
Dockets Home Page | Dockets
Contacts and Location | Operating
Status | Item
Code Definitions | Federal
Register
FDA Home Page | Search
FDA Site | FDA A-Z Index
| Contact FDA
FDA/Dockets Management |
