Global Reach Health – Page 83 – Global Reach Health

January 6, 2020

Avastin Biosimilar Zirabev Launched

January 6, 2020 – Pfizer has announced the launch of ZirabevTM (bevacizumab-bvzr), its biosimilar for Genentech’s Avastin® (bevacizumab). Zirabev is indicated to treat certain patients who have cervical cancer, colorectal cancer, glioblastoma, non-squamous non-small cell lung cancer (NSCLC)

December 31, 2019

Aurobindo Voluntarily Recalls One Lot of Mirtazapine Tablets

December 31, 2019 –Aurobindo Pharma has announced a voluntary recall of one lot of Mirtazapine Tablets due to a labeling error. Bottles belonging to lot number 03119002A3 may be labeled as containing 7.5mg tablets when in fact they contain 15mg tablets.

December 31, 2019

Lynparza Receives New Pancreatic Cancer Indication

December 31, 2019 –The U.S. FDA has approved a new indication for Lynparza® (olaparib), manufactured by AstraZeneca Pharmaceuticals. The product is now indicated to provide first-line maintenance treatment for patients who have deleterious or suspected deleterious gBRCAm

December 26, 2019

Zilretta Receives Label Update

December 26, 2019 –The U.S. FDA has approved updates to the product label for Zilretta® (triamcinolone acetonide extended release injectable suspension), manufactured by Flexion Therapeutics. Zilretta is a synthetic corticosteroid indicated for use as an intra-articular injection to manage osteoarthritis pain

December 26, 2019

Fiasp Indication Expanded to Include Pediatric Patients

December 26, 2019 –The U.S. FDA has approved an expanded indication for Fiasp® (insulin aspart injection), manufactured by Novo Nordisk. Originally approved in 2017 to improve glycemic control in adults who have diabetes mellitus, the product is now also approved to treat pediatric patients.

December 24, 2019

Mycamine Approved for New Indication

December 24, 2019 –The U.S. FDA has approved a new indication for Mycamine® (micafungin for injection), manufactured by Astellas Pharmaceuticals. The product is now indicated to treat candidemia, acute disseminated candidiasis, and Candida peritonitis and abscesses without

December 24, 2019

First Generics for Eliquis Approved

December 24, 2019 –The U.S. FDA has approved the first generics for Eliquis® (apixaban – Bristol-Myers Squibb) tablets. The generics, which are manufactured by Mylan Pharmaceuticals and by Micro Labs, are approved for the same indications as the brand name product.

December 23, 2019

Ubrelvy Approved to Treat Migraines

December 23, 2019 –The U.S. FDA has approved UbrelvyTM (ubrogepant) tablets, manufactured by Allergan, to provide acute treatment of migraine with or without aura in adults. Ubrelvy is the first drug in the calcitonin gene-related peptide (CGRP) receptor antagonist class approved for the acute treatment