In the United States, the marketing approval does not contain these restrictions, though the label contains prominent warnings of skin reactions. The initial approval by the Food and Drug Administration of the United States (December 1999) encompassed these indications:

Acute exacerbations of chronic bronchitis
Acute bacterial sinusitis
Community acquired pneumoniaAdditional indications approved by the Food and Drug Administration:

April 2001: Uncomplicated skin and skin-structure infections
May 2004: Community-acquired pneumonia caused by multidrug-resistant Streptococcus pneumoniae
June 2005: Complicated skin and skin-structure infections
November 2005: Complicated intra-abdominal infectionsThe European Medicines Agency has advised that, for pneumonia, acute bacterial sinusitis, and acute exacerbations of COPD, it should only be used when other antibiotics are inappropriate.Oral and intravenous moxifloxacin have not been approved for children. Several drugs in this class, including moxifloxacin, are not licensed by the Food and Drug Administration for use in children, because of the risk of permanent injury to the musculoskeletal system. Moxifloxacin eye drops are approved for conjunctival infections caused by susceptible bacteria.Recently, alarming reports of moxifloxacin resistance rates among anaerobes have been published. In Austria 36% of Bacteroides have been reported to be reistant to moxifloxacin, while in Italy resistance rates as high as 41% have been reported. Susceptible bacteria
A broad spectrum of bacteria is susceptible, including the following:

Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae
Haemophilus influenzae
Klebsiella spp. Moraxella catarrhalis
Enterobacter spp. Mycobacterium spp.
Ranking 140th within the top 200 prescribed drugs in the United States for 2007, Avelox generated sales of $697.3 million worldwide.Moxifloxacin is also manufactured by Alcon as Vigamox. Patent
A United States patent application was made on 30 June 1989, for Avelox, Bayer A.G. being the assignee, which was subsequently approved on 5 February 1991. This patent was scheduled to expire on 30 June 2009. However, this patent was extended for an additional two and one half years on 16 September 2004, and as such was not expected to expire until 2012. Moxifloxacin was subsequently (ten years later) approved by the FDA for use in the United States in 1999. At least four additional United States patents have been filed regarding moxifloxacin hydrochloride since the 1989 United States application, as well as patents outside of the US. Society and culture
Regulatory actions
Regulatory agencies have taken actions to address certain rare but serious adverse events associated with moxifloxacin therapy. Based on its investigation into reports of rare but severe cases of liver toxicity and skin reactions, the European Medicines Agency recommended in 2008 that the use of the oral (but not the IV) form of moxifloxacin be restricted to infections in which other antibacterial agents cannot be used or have failed. Similarly, the Canadian label includes a warning of the risk of liver injury.The U.S. label does not contain restrictions similar to the European label, but a carries a "black box" warning of the risk of tendon damage and/or rupture and warnings regarding the risk of irreversible peripheral neuropathy.