FDA Double Standard ??
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Today RP gets fast track approval of their Synercid... even though the study didn't prove the drug was safe or effective....AND the FDA also approved Synercid to treat patients with complicated skin and skin structure infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.
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LOCILEX, like other magainins, selectively inserts itself in the membrane of target cells and demonstrates rapid killing by forming ion-channels that allow uncontrolled passage of water and salts. This mechanism, which involves a direct attack on the integrity of the bacterial membrane, is less vulnerable to circumvention by genetic mutation, an event that typically underlies resistance to conventional antibiotics. Bacteria that are resistant to other antibiotics such as mupirocin, gentamicin, ciprofloxacin, penicillin, methicillin, erythromycin and others, do not show cross resistance to LOCILEX in preclinical or clinical testing to date.
Currently, no topical antibiotics are approved for the treatment of infected diabetic ulcers. A broad spectrum topical therapy that could address the range of organisms found in diabetic ulcers (including resistant organisms) and preclude side effects associated with systemic therapy would be of significant clinical value.
HUH ?? |
