GlobalReach Health – Page 89 – Global Reach Health

January 13, 2020

Numbrino Approved as a Local Anesthetic

January 13, 2020 – The U.S. FDA has approved Numbrino® (cocaine hydrochloride nasal solution 4%), a nasal spray manufactured by Lanett Company and indicated to provide local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.

January 13, 2020

Valtoco Approved to Treat Epilepsy

January 13, 2020 – The U.S. FDA has approved Valtoco® (diazepam nasal spray), manufactured by Neurelis Pharmaceuticals, to provide acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) that are distinct from a patient's usual

January 10, 2020

Taro Pharmaceuticals Recalls One Lot of Lamotrigine Tablets

January 10, 2020 – Taro Pharmaceuticals has announced the voluntary recall of one lot of Lamotrigine 100mg Tablets. Tablets in lot number 331771 (expiration date June 2021) have been found to be cross contaminated with another drug

January 9, 2020

Ayvakit Approved as First Targeted Therapy for Gastrointestinal Tumors with Rare Gene Mutation

January 9, 2020 – The U.S. FDA has approved AyvakitTM (avapritinib), manufactured by Blueprint Medicines Corporation, to treat adult patients who have unresectable or metastatic gastrointestinal

January 8, 2020

Keytruda Receives New Bladder Cancer Indication

January 8, 2020 – The U.S. FDA has approved a new indication for Keytruda® (pembrolizumab), manufactured by Merck, to treat patients who are ineligible for or have elected not to undergo cystectomy and have been diagnosed with high-risk, non-muscle invasive bladder cancer (NMIBC)

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.