Global Reach Health – Page 93 – Global Reach Health

December 5, 2018

Tris Pharmaceuticals Recalls Infants’ Ibuprofen

December 5, 2018 – Tris Pharmaceuticals has voluntarily recalled three lots of over-the-counter (OTC) 50mg/1.25mL Infants’ Ibuprofen Concentrated Oral Suspension. The recalled products may contain a higher concentration of ibuprofen than specified. According to the recall announcement, there is a remote possibility that infants may be at risk of kidney injury

December 3, 2018

Dextenza Approved to Treat Pain Following Ophthalmic Surgery

December 3, 2018 – The U.S. FDA has approved Dextenza® (dexamethasone ophthalmic insert) 0.4mg, manufactured by Ocular Therapeutix, to treat ocular pain following ophthalmic surgery. The product is the first FDA-approved intracanalicular (placed in a small channel or duct) insert for drug delivery. In clinical studies, 77-80% of patients treated

December 1, 2018

Generics to Become Available for Epclusa and Harvoni

December 1, 2018 – According to Asegua Therapeutics, a subsidiary of Gilead Sciences, generic versions of Epclusa® (sofosbuvir/velpatasvir) and Harvoni® (ledipasvir/sofosbuvir) should be available on the U.S. market in January 2019. Both Epclusa and Harvoni are Gilead products, and Asegua’s generics will be considered authorized generics.

November 29, 2018

FDA Issues Lemtrada Safety Alert

November 29, 2018 – Patients with multiple sclerosis (MS) who are treated with Lemtrada® (alemtuzumab) may be at risk for rare but serious cases of stroke, as well as tears in the lining of arteries (arterial dissection) located in the head and neck. These events can lead to death or permanent disability. In most instances, patients developed symptoms within one day of receiving Lemtrada.

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.