Crisaborole ointment, 2% (Eucrisa, Pfizer) has been approved for use in pediatric patients with atopic dermatitis as young as 3 months of age.
The FDA previously approved sofosbuvir and velpatasvir to treat HCV in adults.
Pyrimethamine (Daraprim) tablets are used to treat toxoplasmosis.
Officials with the FDA have approved ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc.) injection 100 mg/mL.
Fidaxomicin (Dificid, Merck) is indicated in adults and pediatric patients aged 6 months and older for the treatment of Clostridioides difficile-associated diarrhea.
Our most-read FDA approval articles from 2019.
Ubrogepant (Ubrelvy) is the first oral calcitonin gene-related peptide receptor antagonist approved by the FDA for the acute treatment of migraine.
This is the eighth indication approved for Xarelto.
Drug is the only respiratory therapy that can be given at home every 8 weeks.
Blockbuster drug could be key to Humira’s successor.