Global Reach Health News – Page 69

January 4, 2021

Nostrum Laboratories Includes Additional Lot in Metformin Recall

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

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

December 22, 2020

Brand Medications with Generic Alternatives Anticipated to be Approved in January

Adverse reactions or quality problems experienced with the use of a recalled product can be reported to the FDA’s MedWatch Adverse Event Reporting

December 22, 2020

New Indication for Kineret to Treat Ultra-Rare Genetic Disorder

December 22, 2020 – The U.S. FDA has approved a new indication for Kineret® (anakinra), manufactured by Sobi. The drug is now indicated to treat deficiency of IL-1 receptor antagonist.