News – Page 90 – Global Reach Health

December 6, 2019

Avsola Approved as Remicade Biosimilar

December 6, 2019 – The U.S. FDA has approved AvsolaTM (infliximab-axxq), manufactured by Amgen, as a biosimilar for Janssen’s Remicade® (infliximab). It is the fourth Remicade biosimilar to receive FDA approval. Like Remicade, Avsola is approved to treat certain patients who have rheumatoid arthritis

December 6, 2019

First Generics Approved for MS Drug Gilenya

December 6, 2019 – The U.S. FDA has approved the first generics for Novartis’s Gilenya® (fingolimod), which is approved to treat relapsing forms of multiple sclerosis (MS) – including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease – in patients who are at

December 3, 2019

New Lung Cancer Indication for Tecentriq

December 3, 2019 – The U.S. FDA has approved a new indication for Tecentriq® (atezolizumab), manufactured by Genentech. The product is now indicated for use in combination with chemotherapy (paclitaxel protein-bound and carboplatin) to provide first-line treatment of metastatic non-squamous

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