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 Approves Subcutaneous Tecentriq to Treat Multiple Cancers
September 13th 2024Tecentriq Hybreza can be administered over seven minutes, compared with 30 to 60 minutes for IV infusion of Tecentriq. There is no word yet on when Tecentriq Hybreza will be available or what the price will be.
Read More
FDA Warns of Liver Injury with Veozah for Hot Flashes
September 12th 2024The FDA has identified a probable case of serious drug induced liver injury that occurred in a woman in the United States who had received Veozah. The agency is requiring additional liver blood testing after starting therapy.
Read More
