GlobalReach Health – Page 94 – Global Reach Health

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.

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).

September 13, 2019

FDA Issues Safety Communication for Ibrance, Kisqali, and Verzenio

September 13, 2019 – The U.S. FDA has warned that Ibrance® (palbociclib – Pfizer), Kisqali® (ribociclib – Novartis), and Verzenio® (abemaciclib – Eli Lilly) may cause rare but severe inflammation of the lungs in some patients being treated for advanced breast cancer. As a result, the agency is requiring new warnings be added to the prescribing information