Global Reach Health – Page 86 – Global Reach Health

January 8, 2020

Nizatidine and Ranitidine Products Recalled Due to NDMA

January 8, 2020 – Several products used to treat gastrointestinal (GI) conditions have been voluntarily recalled due to the presence or potential presence of N-nitrosodimethylamine (NDMA). NDMA is a known environmental contaminant found in food and water and is considered a probable human

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.