Global Reach Health News

January 6, 2021

Production of Catapres for Hypertension Discontinued

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

Authorized Generic for Amitiza Approved

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

Chlorhexidine Gluconate Oral Rinse Recall Expanded

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

First Generic of Glucagon for Injection Approved

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 23, 2020 – The U.S. FDA has approved Gemtesa® (vibegron), manufactured by Urovant Sciences, to treat overactive bladder (OAB) with symptoms of urge urinary incontinence
December 22, 2020

COVID19 Vaccines and other Regulatory Highlights

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
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