Pharmaceutical News – Page 15 – Global Reach Health

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

October 2, 2019

NDMA Identified in OTC and Prescription Ranitidine

October 2, 2019 – The U.S. FDA has become aware that some products containing ranitidine, the active ingredient in Zantac®, contain low levels of N-itrosodimethylamine (NDMA), a probable human carcinogen (cancer-causing agent). NDMA is a known environmental contaminant found in water and food such as meats, dairy products, and vegetables.

September 20, 2019

Rybelsus Approved As Novel Treatment for Diabetes

September 20, 2019 – The U.S. FDA has approved Rybelsus® (semaglutide) oral tablets, manufactured by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes mellitus. Rybelsus is the first FDA-approved glucagon-like peptide-1 (GLP-1) receptor agonist with an oral route of administration.

September 19, 2019

New Indication Approved for Pifeltro and Delstrigo

September 19, 2019 – The U.S. FDA has approved a new indication for PifeltroTM (doravirine) tablets and DelstrigoTM (doravirine/lamivudine/tenofovir disoproxil fumarate) tablets, both manufactured by Merck. They are now approved for use in combination with other antiretroviral medicines to replace the current antiretroviral

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.