Pharmaceutical News – Page 87 – Global Reach Health

December 2, 2019

Ogivri Launched as Herceptin Biosimilar

December 2, 2019 – Mylan and Biocon have announced the launch of OgivriTM (trastuzumab-dkst), a biosimilar for Roche’s Herceptin® (trastuzumab). It is the second Herceptin biosimilar to be launched on the U.S. market. The first was Amgen’s KanjintiTM (trastuzumab-anns), which launched in June 2019.

November 25, 2019

New Injectable Form of Methotrexate Approved

November 25, 2019 – The U.S. FDA has approved RediTrexTM (methotrexate) injection, manufactured by Cumberland Pharmaceuticals. The product is indicated to manage severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA) in patients who are intolerant of or have had

November 25, 2019

Toujeo Receives Expanded Indication

November 25, 2019 – The U.S. FDA has approved an expanded indication for Toujeo® (insulin glargine injection) 300 Units/mL, manufactured by Sanofi, to improve glycemic control in patients as young as six years old who have diabetes mellitus. Previously, the product was indicated only for use by adults.

November 25, 2019

Oxbryta Approved to Treat Sickle Cell Disease

November 25, 2019 – The U.S. FDA has approved OxbrytaTM (voxelotor), manufactured by Global Blood Therapeutics, to treat sickle cell disease in adults and pediatric patients who are at least 12 years of age. It is the first in a new class of drugs known as sickle hemoglobin polymerization inhibitors, and the first

November 22, 2019

New Oral Film Form of Riluzole Approved to Treat ALS

November 22, 2019 – The U.S. FDA has approved ExservanTM (riluzole), manufactured by Aquestive Therapeutics, to treat amyotrophic lateral sclerosis (ALS). It is the first FDA-approved riluzole product available in an oral film dosage form. ALS is a rare group of neurological diseases that affect approximately 16,000 individuals in the United States

September 19, 2019

Torrent Pharmaceuticals Expands Recall of Losartan Products

September 19, 2019 – Torrent Pharmaceuticals has expanded its voluntary recall of Losartan Potassium Tablets USP and Losartan Potassium/ Hydrochlorothiazide (HCTZ) Tablets USP to include five additional lots. Three of the lots are for losartan potassium, while two are losartan potassium/HCTZ.

September 17, 2019

Keytruda and Lenvima Approved to Treat Endometrial Cancer

September 17, 2019 – The U.S. FDA has announced the first drug approval granted through Project Orbis, which provides a framework for concurrent submission and review of oncology drugs among international partners. Through the program, the FDA, the Australian Therapeutic Goods Administration (TGA), and Health Canada granted

September 17, 2019

Erleada Receives New Indication

September 17, 2019 – The U.S. FDA has approved a new indication for Erleada® (apalutamide), manufactured by Janssen Pharmaceuticals. The product is now indicated to treat metastatic castration-sensitive prostate cancer (mCSPC).