Kloxxado™ (naloxone) – New drug approval
The FDA announced the approval of Hikma Pharmaceuticals’ Kloxxado (naloxone), for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients. April 30, 2021
Absorica® (isotretinoin) – First-time generic
Teva launched an AB-rated generic version of Sun’s Absorica (isotretinoin) capsules. April 30, 2021
Farxiga® (dapagliflozin) – New indication
The FDA announced the approval of AstraZeneca’s Farxiga (dapagliflozin), to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease (CKD) at risk of progression. April 30, 2021
Ferriprox® (deferiprone) – New indication, expanded indication
Chiesi Global Rare Diseases announced the FDA approval of Ferriprox (deferiprone), for the treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with sickle cell disease or other anemias. May 1, 2021
Natroba® (spinosad) – New indication
The FDA approved ParaPRO’s Natroba (spinosad), for the topical treatment of scabies infestations in adult and pediatric patients 4 years of age and older. April 28, 2021