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FDA News Briefs for Friday, May 3, 2019

May 3, 2019

These Food and Drug Administration (FDA) developments came in this week:


FDA Approves First Vaccination for Dengue Disease

The FDA has approved Dengvaxia (Sanofi Pasteur), the first vaccine for the prevention of dengue disease (serotypes 1 through 4) in patients aged 9 through 16 years with laboratory-confirmed infection and who reside in endemic U.S. regions. This live attenuated vaccine is administered as 3 separate injections in patients previously infected by dengue. More Information.


FDA Expands Indications for Tibsovo

The FDA has approved a supplemental new drug application for Tibsovo (ivosidenib; Agios Pharmaceuticals) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) inhibitor in adult patients ≥ 75 years of age or who have comorbidities that preclude use of intensive induction chemotherapy. Tibsovo was previously approved for adult patients with relapsed/refractory IDH1-positive AML. More Information.  


Ketorolac Tromethamine Injection Recalled

Sagent Pharmaceuticals has issued a recall of ketorolac tromethamine injection, 60 mg/2 mL due to sterility concerns. Microbial growth was detected in 1 lot, and intravenous administration may cause serious infection resulting in shock and/or death. More Information.