FDA Gives Tentative OK for Generic Antibiotic

Mylan Pharmaceuticals has received tentative approval from the FDA for a generic version of Pfizer’s Zyvox 600-mg tablets.

Zyvox (linezolid) is an antibiotic used to treat nosocomial pneumonia and complicated skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes or Streptococcus agalactiae.

Results from an open-label study in March 2007 showed use of the drug increased patients’ risk of dying from Gram-negative, catheter-related infections, according to an FDA MedWatch report.

The study compared Zyvox with the older antibiotics vancomycin, oxacillin and dicloxacillin in seriously ill patients with catheter-related bloodstream infections, including catheter-site infections, according to the FDA.

“Patients treated with linezolid had a higher chance of death than did patients treated with any comparator antibiotic, and the chance of death was related to the type of organism causing the infection,” the FDA said.