News – Page 96 – Global Reach Health

December 14, 2018

Herzuma Approved as Biosimilar to Herceptin

December 14, 2018 – The U.S. FDA has approved Herzuma® (trastuzumab-pkrb), manufactured by Celltrion and Teva, as a biosimilar to Genentech’s Herceptin® (trastuzumab). It is indicated to treat HER2-overexpressing breast cancer, as verified by an FDA-approved companion diagnostic test. For adjuvant breast cancer, Herzuma should be used

December 11, 2018

Tolsura Approved to Treat Fungal Infections

December 11, 2018 – The U.S. FDA has approved TolsuraTM (SUBA®-itraconazole), manufactured by Mayne Pharma Group, to treat certain serious fungal infections that typically occur in individuals who have weakened immune systems and are associated with high rates of fatality or long-term complications. The drug is indicated for use in individuals who have blastomycosis

December 6, 2018

Tecentriq Receives New Indication

December 6, 2018 – The U.S. FDA has approved a new indication for Tecentriq® (atezolizumab), manufactured by Genentech. The drug is now approved to provide first-line treatment, when used in combination with Genentech’s Avastin® (bevacizumab), for patients who have metastatic non-squamous non-small cell lung cancer (NSCLC) with

December 6, 2018

Symjepi to Launch at Lower Cost than EpiPen Generic

December 6, 2018 – Sandoz has announced that Symjepi® (epinephrine) 0.3mg injection will launch in the United States during the first quarter of 2019 at a list price of $250 per pack – more than 16% less than the list price of Mylan and Teva’s generics for the EpiPen® (epinephrine) 0.3mg auto-injector. Each pack contains two doses of Symjepi.

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.