FDA News Briefs for Friday, January 26, 2018January 26, 2018
These Food and Drug Administration (FDA) developments came in this week:
FDA Expands Indications for Trulance
The FDA has approved Trulance (plecanatide; Synergy Pharmaceuticals Inc.) for the once-daily treatment of irritable bowel syndrome with constipation in adults. The agency previously approved Trulance for the treatment of adults with chronic idiopathic constipation. More Information.
FDA Issues Draft Guidance on Development of Drug Combos for Hypertension
The FDA has issued a draft guidance to assist sponsors in the clinical development of fixed-dose combination drugs for the treatment of hypertension. The guidance pertains to the development of two-drug combinations of previously approved drugs. The agency notes, however, that the guidance is also readily applicable to the development of ≥ 3 drug combination products. More Information.
FDA and FTC Warn Against Sale of Unapproved Opioid Cessation Products
The FDA and the Federal Trade Commission (FTC) have posted joint warning letters to the marketers and distributors of 12 opioid cessation products for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal. More Information.