New development pathway significantly expands addressable patient population for IV Choline ChlorideIV Choline Chloride has the potential to become the first FDA-approved IV formulation of choline for...
The eyedrop formulation of UNR844 (lipoic acid/choline ester chloride) was acquired as part of the group’s buyout of privately-held ophthalmology biotech Encore Vision in 2017, and was designed to work by restoring the elasticity of the eye’s lens that declines with age.
Enforcement Report - Week of August 14, 2019
Enforcement Report - Week of June 19, 2019
U.S. District Judge Keith P. Ellison for the Southern District of Texas signed and entered a consent decree of permanent injunction, ordering a Texas-based company and its owners to stop producing compounded drugs intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements. According to the complaint, despite previous warnings from the U.S. Food and Drug Administration, Pharm D Solutions, LLC, as well as the company’s owners, Luis R. De Leon and Juan C. De Leon, continued to violate the law, putting patients at risk.
Enforcement Report - Week of May 8, 2019
NEW YORK--(BUSINESS WIRE)--ArTara Therapeutics, a clinical-stage company developing treatments for rare diseases with significant unmet needs, today announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss study of Intravenous (IV) Choline Chloride substrate replacement for patients with Intestinal Failure Associated Liver Disease (IFALD).
Inventive Infusion Solutions Receives FDA Form 483