GlobalReach Health – Page 92 – Global Reach Health

December 16, 2019

Xtandi Receives New Indication

December 16, 2019 – The U.S. FDA has approved a new indication for Xtandi® (enzalutamide), manufactured by Pfizer, to treat patients who have metastatic castration-sensitive prostate cancer (mCSPC). The product was first approved in 2012 and is also indicated to treat castration-resistant

December 13, 2019

Expanded Indication Approved for Tiglutik

December 13, 2019 – The U.S. FDA has approved an expanded indication for Tiglutik® (riluzole) oral suspension, manufactured by ITF Pharma. Under the expansion, the product can now be administered via percutaneous endoscopic gastrostomy (PEG) tubes to treat amyotrophic lateral sclerosis (ALS).

December 13, 2019

Vascepa Receives New Indication to Reduce Cardiovascular Risk

December 13, 2019 – The U.S. FDA has approved a new indication for Vascepa® (icosapent ethyl) capsules, manufactured by Amarin. The product is now indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina

December 13, 2019

First Interoperable Automated Glycemic Controller Approved for Use with Insulin Pumps

December 13, 2019 – The U.S. FDA has approved the t:slim X2TM insulin pump with Control-IQTM technology from Tandem Diabetes Care. Control-IQ is the first FDA-approved software in a new class of devices known as interoperable automated glycemic controllers that can help ensure proper insulin dosing.

December 12, 2019

NuvaRing Generic Approved to Prevent Pregnancy

December 12, 2019 – The U.S. FDA has approved Amneal Pharmaceuticals' generic version of Merck's NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring). Amneal’s generic will be marketed under the name EluRyngTM and is the first generic alternative to NuvaRing to become available on the U.S. market.

December 12, 2019

Xeljanz XR Receives New Indication for Ulcerative Colitis

December 12, 2019 – The U.S. FDA has approved a new indication for Xeljanz® XR (tofacitinib) 11mg and 22mg extended-release tablets, manufactured by Pfizer. Xeljanz XR is now approved to treat moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response or are

December 12, 2019

Vyondys 53 Approved for Duchenne Muscular Dystrophy

December 12, 2019 – The U.S. FDA has approved Vyondys 53TM (golodirsen) injection, manufactured by Sarepta Pharmaceuticals, to treat Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene amenable to exon 53 skipping. Approximately 8% of DMD patients are eligible

December 10, 2019

First Afinitor Generic Launched

December 10, 2019 – Par Pharmaceuticals has launched the first generic for Novartis’s Afinitor® (everolimus) tablets. Everolimus is indicated to treat certain patients who have breast cancer, neuroendocrine tumors, renal cell carcinoma (RCC), or tuberous sclerosis complex (TSC).