August 21, 2019
Adverse reactions or quality problems experienced with the use of a recalled product can be reported to the FDA's MedWatch Adverse Event Reporting Program online, by mail, or by fax.
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News
August 20, 2019
August 20, 2019 – The U.S. FDA has approved a new indication for Myobloc® (rimabotulinumtoxinB), manufactured by US WorldMeds, to treat chronic sialorrhea (excessive drooling) in adults.
July 26, 2019
July 26, 2019 – The U.S. FDA has issued a safety communication cautioning that Xeljanz® (tofacitinib) and
Xeljanz XR® (tofacitinib), manufactured by Pfizer, may increase the risk of blood clots and death when taken at higher doses.
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
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 21, 2018
December 21, 2018 – The U.S. FDA has approved UltomirisTM (ravulizumab), manufactured by Alexion Pharmaceuticals, to treat adult patients who have paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disorder.
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.