FDA actions in brief
FDA approved moxifloxacin (Avelox, Schering-Plough) tablets and injection for the once-daily treatment of adults with complicated skin and skin structure infections (cSSSIs) caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.
FDA approved moxifloxacin (Avelox, Schering-Plough) tablets and injection for the once-daily treatment of adults with complicated skin and skin structure infections (cSSSIs) caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.
Isosorbide dinitrate/hydralazine hydrochloride (BilDil, NitroMed) was approved for the treatment of heart failure in self-identified Black patients.
An expanded indication was approved for mixed amphetamine salts (Adderall XR, Shire) to include the once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years. The ADHD therapy was previously indicated only for the treatment of children aged 6 to 12 years and adults aged 18 years and older.
FDA approved topiramate tablets and sprinkle capsules (Topamax, Ortho-McNeil) as initial monotherapy in patients aged 10 years and older with partial-onset or primary generalized tonic-clonic seizures.
FDA Issues Complete Response for High-Dose Opioid Rescue Med
July 16th 2024OX124 is a nasal spray provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA would like to see additional technical data, as well as data on whether patients can correctly use the device.
Read More
