GlobalReach Health – Page 98 – Global Reach Health

December 20, 2018

New Guidance on Acceptable NDMA and NDEA Levels in ARBs

December 20, 2018 – The U.S. FDA has issued new guidance on the acceptable level of nitrosamine impurities in angiotensin II receptor blockers (ARBs). A number of companies issued recalls in 2018 related to the presence of nitrosamine compounds in their ARB products, which have included valsartan, losartan, and irbesartan.

December 20, 2018

Updates to Fluoroquinolone Safety Alert

December 20, 2018 – The U.S. FDA has updated a safety alert originally issued in May 2017 regarding fluoroquinolone antibiotics. These antibiotics, when used systemically, may raise a patient’s risk of rare but serious ruptures or tears in the aorta. This can lead to life-threatening bleeding, and may occur with either oral or injectable fluoroquinolones.

December 20, 2018

Torrent Pharmaceuticals Recalls Losartan

December 20, 2018 – Drug manufacturer Torrent Pharmaceuticals has voluntarily recalled two lots of Losartan Potassium Tablets due to the presence of N-nitrosodiethylamine (NDEA). NDEA is considered a probable human carcinogen, and has been detected in other “sartan” products during the latter half of 2018.

December 19, 2018

Lynparza Receives New Indication

December 19, 2018 – The U.S. FDA has approved a new indication for Lynparza® (olaparib), manufactured by AstraZeneca and Merck. The drug is now approved to provide maintenance treatment for adult patients who have deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced ovarian cancer

December 19, 2018

Keytruda Receives New Indication for Merkel Cell Carcinoma

December 19, 2018 – The U.S. FDA has approved a new indication for Keytruda® (pembrolizumab), manufactured by Merck. Under the new indication, Keytruda is now approved to treat of adult and pediatric patients who have recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

December 18, 2018

FDA Advisory Panel Recommends Prescribing Naloxone in Conjunction with Opioids

December 18, 2018 – A U.S. FDA advisory panel has voted 12-11 in favor of prescribing naloxone concurrently with opioid painkillers. A reversal drug available under various brand names and as a generic, naloxone has gained significant attention in the media for its potential to save the lives of individuals who have overdosed on opioids.

December 17, 2018

First Generic for Canasa Approved

December 17, 2018 – The U.S. FDA has approved Mylan’s generic for Allergan’s Canasa® (mesalamine) 1,000mg rectal suppositories. This is the first generic for the product to receive FDA approval, and Mylan will have 180 days of exclusivity. Canasa and its generic are indicated to treat mildly to moderately active ulcerative proctitis, an inflammatory bowel disease and form of ulcerative colitis (UC).

December 14, 2018

Motegrity Approved to Treat Chronic Idiopathic Constipation

December 14, 2018 – The U.S. FDA has approved MotegrityTM (prucalopride), manufactured by Shire, to treat chronic idiopathic constipation (CIC) in adult patients. It is the first serotonin-4 receptor agonist to receive approval for a CIC indication.An estimated 35 million adults in the United States have CIC. Women, the elderly, and individuals