Regulatory Focus™ > News Articles > J&J Antibiotic Approved Via 'Animal Rule' Pathway

J&J Antibiotic Approved Via 'Animal Rule' Pathway

Posted 30 April 2012 | By

After being backed by a US Food and Drug Administration (FDA) advisory committee, life sciences manufacturer Johnson & Johnson (J&J) has won FDA approval for Levaquin (levofloxacin), an antibiotic intended to treat pneumonic plague.

The drug's approval is notable because it utilizes a rarely-used approval pathway known as the 'Animal Rule' pathway. The pathway allows sponsors of products intended to treat very dangerous or contagious conditions to forgo clinical trials and instead test the products on human analogues such as monkeys or pigs.

"The FDA approved Levaquin for plague after tests on African green monkeys infected with the bacteria in a lab found 94% of the monkeys given Levaquin survived," reports The Associated Press.

None of the animals given a placebo survived, noted Med Page Today.

Levaquin is manufactured by J&J subsidiary Jenssen Pharmaceuticals.

Read more:

Med Page Today - Levaquin OK'd to Treat Plague

PharmaPro - FDA Approves Antibiotic to Treat, Prevent Plague

Med City News - FDA approves Levaquin to combat pneumonic plague bioterrorist attack

Regulatory Focus - FDA Close to Approving J&J Drug Via Animal Rule Pathway

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