Is Polymyxin B / Colistin legal in the US?
Yes, FDA approved for serious infections from germs they can kill.
Both are FDA-approved antibiotics. Injectable polymyxin B is approved for serious infections caused by susceptible Gram-negative bacteria, with a boxed warning about kidney toxicity, nerve toxicity and the risk of respiratory paralysis; colistimethate sodium for injection, first approved as Coly-Mycin M, is approved for acute or chronic infections due to susceptible Gram-negative bacilli, mainly Pseudomonas aeruginosa. Drugs@FDA lists the first polymyxin B injection approval in 1964 and Coly-Mycin M in 1970, and both drugs are now sold as generics.
Read the full Polymyxin B / Colistin page
More on Polymyxin B / Colistin
Citations
- Paul 2018, Lancet Infect Dis: colistin alone versus colistin plus meropenem for carbapenem-resistant Gram-negative infections (AIDA) doi.org
- Polymyxin B for injection prescribing information drugs.com
- openFDA Drugs@FDA: Coly-Mycin M (NDA 050108) approval record api.fda.gov
Reference information only, not medical advice. Drawn from the Polymyxin B / Colistin article, fact-checked against the cited sources. No dosing anywhere on this site.