Global Reach Health – Page 88 – Global Reach Health

December 19, 2019

Arazlo Approved to Treat Acne

December 19, 2019 – The U.S. FDA has approved ArazloTM (tazarotene) lotion 0.045%, manufactured by Ortho Dermatologics. The product is indicated to provide topical treatment of acne vulgaris in patients who are at least nine years of age. Although the active ingredient has been FDA approved since 1997

December 18, 2019

Padcev Approved to Treat Bladder Cancer

December 18, 2019 – The U.S. FDA has granted accelerated approval to PadcevTM (enfortumab vedotin- ejfv), manufactured by Astellas and Seattle Genetics, to treat adult patients who have locally advanced or metastatic urothelial cancer. Patients must have already been treated with a platinum

December 18, 2019

Glenmark Recalls Prescription Ranitidine

December 18, 2019 – Glenmark Pharmaceuticals has halted distribution of both its 150mg and 300mg prescription ranitidine tablets due to the potential for N-nitrosodimethylamine (NDMA) levels in excess of the FDA’s currently established limits. The company has also recalled all unexpired lots on the United

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.