Global Reach Health – Page 89 – Global Reach Health

December 17, 2018

First Generic for Canasa Approved

December 17, 2018 – The U.S. FDA has approved Mylan’s generic for Allergan’s Canasa® (mesalamine) 1,000mg rectal suppositories. This is the first generic for the product to receive FDA approval, and Mylan will have 180 days of exclusivity. Canasa and its generic are indicated to treat mildly to moderately active ulcerative proctitis, an inflammatory bowel disease and form of ulcerative colitis (UC).

December 14, 2018

Motegrity Approved to Treat Chronic Idiopathic Constipation

December 14, 2018 – The U.S. FDA has approved MotegrityTM (prucalopride), manufactured by Shire, to treat chronic idiopathic constipation (CIC) in adult patients. It is the first serotonin-4 receptor agonist to receive approval for a CIC indication.An estimated 35 million adults in the United States have CIC. Women, the elderly, and individuals

December 14, 2018

Nplate Receives Expanded Indication

December 14, 2018 – The U.S. FDA has approved an expanded indication for Nplate® (romiplostim), manufactured by Amgen. It is now approved to treat children as young as one year of age who have chronic immune thrombocytopenic purpura (ITP). Nplate was previously approved only for use in adult patients.

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