International Medical Assistance – Page 68

January 7, 2021

Kala Pharmaceuticals Launches Dry Eye Treatment Eysuvis

January 7, 2021 – Kala Pharmaceuticals has announced the launch of EysuvisTM (loteprednol etabonate ophthalmic suspension), which received U.S. FDA approval on October 26, 2020

January 6, 2021

FDA Releases Report on 2021 Novel Drug Approvals

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.

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

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