Federal Register Notice: FDA has determined that Roxane Labs’ Orlaam (levomethadyl acetate hydrochloride (HCl)) oral solution, 10 mg/mL was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs for levomethadyl acetate HCl oral solution, 10 mg/mL, if all other legal and regulatory requirements are met. To view this notice, click here.
