Nuflor - What's New

Nuflor® Antibiotic Receives FDA Approval for Additional Bovine Respiratory Disease (BRD) Label Claim

Label now says NUFLOR antibiotic kills two of the major bacteria (Mannheimia haemolytica and Histophilus somni) that cause BRD

KENILWORTH, N.J. – Schering-Plough Animal Health today announced that NUFLOR (florfenicol) antibiotic has received approval from the U.S. Food and Drug Administration (FDA) for an updated label to include the claim that the antibiotic kills bacteria associated with bovine respiratory disease (BRD). BRD is a major health problem in cattle and the most significant cause of economic loss for the cattle industry.

“The new label claim for NUFLOR demonstrates the efficacy of this antibiotic in treating BRD,” said Rick Sibbel, DVM, Schering-Plough. “BRD is a serious condition and most cattle affected by BRD will suffer irreversible damage unless the disease is treated effectively.”

The product’s previous label claim was for inhibiting bacteria. With the new FDA approval, the NUFLOR product can now carry the label claim that it has bactericidal activity (i.e., kills) against some strains of the major bacteria that cause BRD: Mannheimia haemolytica and Histophilus somni. Testing demonstrated that 99.9 percent of the bacteria were killed in 24 hours. After injection, NUFLOR continues to kill the bacteria for a total of 68 hours. In addition, NUFLOR inhibits a third major bacteria, Pasteurella multocida, for 67 hours.

NUFLOR is a broad-spectrum antibiotic that has been used to treat more than 60 million cattle worldwide. It was developed by Schering-Plough Animal Health and first introduced in the U.S. in 1996. NUFLOR is available by prescription only.

About BRD

A bacterial invasion of the lungs is a major component of BRD. The typical symptoms of BRD are associated with inflammation of the lungs, and include breathlessness, fever, excess mucus, coughing and loss of appetite. BRD, which is the most significant cause of economic loss for the cattle industry, is universally treated with an antibiotic.

About Schering-Plough

Intervet/Schering-Plough Animal Health is the global animal health business of Schering-Plough (NYSE: SGP). Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.