Additional Regulatory History
See also Levaquin regulator history
Floxin:
- December 28, 1990 The approval of the new drug application (NDA for floxacin).
- December 28, 1990 to March 6, 2004 Fourteen years worth of data has been removed from the FDA website. As such, this information is no longer available. The NDA (new drug application) documents have also been removed from the FDA site. As such the regulatory history begins fourteen years after initial approval beginning with the 2004 changes:
- September 15, 2004 The Tendon effects subsection was revised which minimized the warnings concerning that spontaneous tendon ruptures may be increased in patients receiving corticosteroids with Floxin (ofloxacin—floxacin) and other quinolones. The statement that tendon rupture can occur “at any time” was removed.
- June 14, 2006
The Indications and Usage section of the package insert was revised as follows: “Uncomplicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes, or Proteus mirabilis.”
- June 19, 2007
The Tendon effects subsection was revised to minimize the warnings stating that the risk of serious tendon disorders is higher in those over 65 years of age, especially those on steroids.
- October 3, 2008
Addition of Black Box Warning.
- February 12, 2009
Issuance of a Medication Guide and revisions to include new safety information including the addition of the Black Box Warning to the Medication Guide. The FDA had determined that Ofloxacin poses a serious and significant public health concern, requiring the distribution of a Medication Guide
Note: Although the FDA had requested that the revised labeling (which were to include the Black Box Warnings) accompany the package inserts for any newly shipped products (effective January 2009) there are continuing reports that as of September 2009, that the products continue to contain the older labels, and not the revised labels, and that the Medication Guides (absent of the Black Box Warnings) were not made available for distribution.
- April 30, 2009
Notice given to the FDA of the discontinuance of Floxacin by the manufacturer effective June 18, 2009.
Read more about this topic: Ofloxacin
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