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 Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
Read More
