November 29, 2018

Idhifa Safety Alert Warns of Differentiation Syndrome

November 29, 2018 – The U.S. FDA has issued a safety communication for Idhifa® (enasidenib), saying that the signs and symptoms of differentiation syndrome are not being recognized in patients who receive the drug. Differentiation syndrome is a potentially life-threatening condition that occurs when the body overproduces cytokine proteins that signal inflammatory responses.
November 28, 2018

Truxima, First Rituxan Biosimilar, Approved

November 28, 2018 – The U.S. FDA has approved Truxima® (rituximab-abbs), manufactured by Celltrion, to treat certain adult patients who have non-Hodgkin lymphoma (NHL). This is the first biosimilar for Genentech’s Rituxan® (rituximab) to receive FDA approval. Although biosimilars must be highly similar to the original reference
November 28, 2018

EpiPen Generics Launched

November 28, 2018 – Teva Pharmaceuticals has launched limited quantities of its generic for Mylan's EpiPen® (epinephrine 0.3mg) auto-injectors. Epinephrine auto-injectors are approved to provide emergency treatment of allergic reactions, including anaphylaxis. The release of Teva's generic epinephrine auto-injectors
November 28, 2018

Xospata Approved to Treat Acute Myeloid Leukemia

November 28, 2018 – The U.S. FDA has approved Xospata® (gilteritinib), manufactured by Astellas Pharma, to treat adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation detected by an FDA-approved test. Invivoscribe Technologies’ LeukoStrat CDx FLT3 Mutation Assay has been approved for this purpose.
November 28, 2018

Firdapse Approved to Treat Rare Autoimmune Disorder

November 28, 2018 – The U.S. FDA has approved Firdapse® (amifampridine), manufactured by Catalyst Pharmaceuticals, Inc., to treat adult patients who have Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder. Firdapse is the first FDA-approved treatment for LEMS.
November 26, 2018

New Dosage Form of Actemra Approved

November 26, 2018 – The U.S. FDA has approved the ACTPenTM 162mg/0.9mL prefilled auto-injector, a new dosage form of Genentech's Actemra® (tocilizumab). It is indicated for the treatment of certain patients who have rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA), or systemic juvenile idiopathic arthritis (SJIA).
November 16, 2018

Temixys Approved to Treat HIV

November 16, 2018 – The U.S. FDA has approved TemixysTM (300mg lamivudine/300mg tenofovir disoproxil fumarate), manufactured by Celltrion, for use in combination with other antiretroviral agents to treat HIV-1 infection in adults and pediatric patients who weigh at least 35kg (77 pounds).
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