December 9, 2020
December 9, 2020 – AvKARE of Pulaski, TN, has voluntarily recalled one lot of Sildenafil 100mg tablets and
one lot of Trazodone 100mg tablets after the two products were inadvertently packaged
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December 9, 2020
December 9, 2020 – Torrent Pharmaceuticals has voluntarily recalled one lot of Anagrelide Capsules, USP, following the product’s failure in a dissolution test that is part of routine quality testing.
December 4, 2020
December 4, 2020 –The U.S. FDA has approved a label update for Merck’s Januvia® (sitagliptin), Janumet®
(sitagliptin/metformin hydrochloride), and Janumet® XR (sitagliptin/metformin
December 1, 2020
December 1, 2020 – The U.S. FDA has approved a new indication for Hetlioz® (tasimelteon), manufactured by Vanda Pharmaceuticals. Originally FDA approved in 2014 to treat non-24-hour
November 25, 2020
November 25, 2020 – The U.S. FDA has approved Danyelza® (naxitamab-gqgk), manufactured by Y-
mAbs Therapeutics, for use in combination with granulocyte-macrophage
November 23, 2020
November 23, 2020 – The U.S. FDA has approved OxlumoTM (lumasiran), manufactured by Alnylam
Pharmaceuticals, to treat primary hyperoxaluria type 1 (PH1), lowering urinary oxalate levels
October 22, 2020
October 22, 2020 – The U.S. FDA has approved Veklury® (remdesivir), manufactured by Gilead, to treat
COVID-19 in patients who require hospitalization, are at least 12 years of age
October 22, 2020
October 22, 2020 – October 22, 2020 – Breaking a four-year pattern of approving record numbers of generic drugs, the U.S.
FDA issued 909 generic drug approvals in fiscal year (FY) 2020 compared