FDA actions in brief

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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.

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