Federal Register Notice: FDA has determined that two drug products — Celestone Soluspan (betamethasone sodium phosphate and betamethasone acetate) injection and Celestone (betamethasone sodium phosphate) injection were not withdrawn from sale for reasons of safety or effectiveness. This will allow FDA to approve ANDAs for the two drugs if all other legal and regulatory requirements are met. Future applicants are advised that Celestone Soluspan injection may not be commercially available because, under a consent decree between FDA and the manufacturer, it is being made available in certain instances of medical necessity only. To view this notice, click here.