Fatty Acids Archives

FDA Action Alert: Jazz, ANI and Ultragenyx

Approvals, Cataplexy, Excessive Daytime Sleepiness, Fatty Acids, FDA, FDA/Regulatory, Gels, Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD), Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD), Multiple Sclerosis, Narcolepsy, New Drug Applications, PDUFA, Refusal to File letter, Rheumatoid Arthritis, Supplemental New Drug Application (sNDA), Systemic Lupus Erythematosus (SLE), Ulcerative Colitis

U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.

FDA approves Xeris’ glucagon pen for low blood sugar

Approvals, Blood Sugar Levels, Diabetes, Fatty Acids, FDA, FDA/Regulatory, Glucagon, Hypoglycemia, Insulin, Pancreas, Pre-Filled Pens

The U.S. Food and Drug Administration approved Xeris Pharmaceuticals Inc.’s glucagon pen Gvoke, which aims to treat severely low sugar levels in diabetes patients.

Amarin’s Vascepa cuts occurrence of serious heart problems 30 percent: study

Omega-3

A high dose of Amarin Corp.’s omega-3 drug Vascepa significantly reduced the occurrence of first and subsequent heart attacks, strokes and other serious heart problems in high-risk patients already taking cholesterol medication by even more than initially reported, according to data.