July 25, 2019
July 25, 2019 – The U.S. FDA has approved AccruferTM (ferric maltol), manufactured by Shield Therapeutics, to treat iron deficiency in adults. The product is a new means of treating iron deficiency compared
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December 21, 2018
December 21, 2018 – The U.S. FDA has approved ElzonrisTM (tagraxofusp-erzs), manufactured by Stemline Therapeutics, to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in patients two years of age and older. Elzonris is the first FDA-approved therapy for BPDCN.
December 20, 2018
December 20, 2018 – The U.S. FDA has approved AsparlasTM (calaspargase pegol-mknl), manufactured by Servier Pharmaceuticals, for use in combination with chemotherapy to treat patients who are between the ages of one month and 21 years, and have acute lymphoblastic leukemia (ALL).
December 20, 2018
December 20, 2018 – The U.S. FDA has issued new guidance on the acceptable level of nitrosamine impurities in angiotensin II receptor blockers (ARBs). A number of companies issued recalls in 2018 related to the presence of nitrosamine compounds in their ARB products, which have included valsartan, losartan, and irbesartan.
December 20, 2018
December 20, 2018 – The U.S. FDA has updated a safety alert originally issued in May 2017 regarding fluoroquinolone antibiotics. These antibiotics, when used systemically, may raise a patient’s risk of rare but serious ruptures or tears in the aorta. This can lead to life-threatening bleeding, and may occur with either oral or injectable fluoroquinolones.
December 20, 2018
December 20, 2018 – Drug manufacturer Torrent Pharmaceuticals has voluntarily recalled two lots of Losartan Potassium Tablets due to the presence of N-nitrosodiethylamine (NDEA). NDEA is considered a probable human carcinogen, and has been detected in other “sartan” products during the latter half of
2018.
December 19, 2018
December 19, 2018 – The U.S. FDA has approved a new indication for Lynparza® (olaparib), manufactured by AstraZeneca and Merck. The drug is now approved to provide maintenance treatment for adult patients who have deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced ovarian cancer
December 19, 2018
December 19, 2018 – The U.S. FDA has approved a new indication for Keytruda® (pembrolizumab), manufactured by Merck. Under the new indication, Keytruda is now approved to treat of adult and pediatric patients who have recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).