Mutual Pharmaceutical Company/AR Scientific announced the commercial introduction of QUALAQUIN (quinine sulfate capsules USP, 324 mg) for the treatment of uncomplicated Plasmodium falciparum malaria. QUALAQUIN is the first and only formulation of quinine sulfate to be evaluated and approved by the U.S. Food and Drug Administration (FDA). QUALAQUIN has been designated an orphan drug by the FDA. Yahoo Finance (http://biz.yahoo.com/prnews/060712/nyw082.html?.v=54)
Simplifying Global Compliance
Recommended Products
EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
Editor's Picks
Cerapedics Earns Premarket Approval for Bone Graft
The premarket approval allows the labeling to state that clinical data showed statistical superiority over autologous bone graft was maintained in its second-year follow-up.
Reblozyl Earns FDA’s First Approval for Rare Blood Disorder
Reblozyl was previously granted both fast track and orphan drug designations.
