Levaquin Approval For Plague Carries Just One Postmarketing Requirement
This article was originally published in The Pink Sheet Daily
Study requirement for J&J’s antibiotic is less onerous than the studies that were imposed for the two other products approved under the Animal Rule.
You may also be interested in...
From Monkeys To Men: Panel Will Review Use Of Animal Rule For Filgrastim As Radiation Countermeasure
FDA’s Medical Imaging Drugs and Oncologic Drugs Advisory Committee will discuss whether evidence supports approval of filgrastim as a medical countermeasure for radiation-induced bone marrow injury using the “animal rule.”
Animal Rule Studies Should Be As Well-Designed As Human Clinical Trials, Panel Says
FDA's Anti-Infective Drugs Advisory Committee unanimously said ciprofloxacin and Ortho-McNeil-Janssen Pharmaceuticals Inc.’s Levaquin (levofloxacin) had proven their efficacy for pneumonic plague in studies in African Green Monkeys, but the panel may be less willing to overlook study design flaws in less life-threatening conditions.
Merck’s Postmarketing Study Delays Prompt FDA To Unsheathe New Enforcement Power
Januvia and Janumet are misbranded, FDA tells Merck in a warning letter noting that rodent safety studies for the sitagliptin diabetes drugs were 20 months behind schedule. The letter marks the first time FDA has used its FDAAA powers to take enforcement action against a pharma company for such a delay.