January 6, 2021
January 6, 2021 – The U.S. FDA approved 50 novel drugs in 2021, down from 53 in 2020. Over the last five years, the agency has approved an average of 51 novel drugs per year.
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January 6, 2021
January 6, 2021 – Boehringer Ingelheim has notified the U.S. FDA it will discontinue the manufacturing of
Catapres® (clonidine hydrochloride), a medication approved in the 1970s for use either
January 4, 2021
January 4, 2021 – Nostrum Laboratories has expanded a recall of Metformin HCl Extended Release (ER)
Tablets, USP 750mg, to include one additional lot. The affected product contains
January 4, 2021
January 4, 2021 – The U.S. FDA has approved an authorized generic, distributed by Par Pharmaceutical, for Mallinckrodt Pharmaceuticals’ Amitiza® (lubiprostone) 8mcg and 24mcg capsules
December 31, 2020
December 31, 2020 – Sunstar Americas has expanded its October 2020 recall of Paroex® Chlorhexidine
Gluconate Oral Rinse USP, 0.12%, to include all products with an expiration date
December 29, 2020
December 29, 2020 – The U.S. FDA has approved Amphastar Pharmaceuticals’ generic glucagon for
injection USP, 1mg/vial packaged in an emergency kit. It is the first generic version
December 23, 2020
December 22, 2020
In December 2020, the U.S. FDA granted Emergency Use Authorization to Pfizer/BioNTech and Moderna for vaccines to prevent COVID-19 caused by SARS-CoV-2 infection. Moderna’s vaccine is indicated for use in individuals 18 and up