Zdrowie i gospodarka · 6.06.2011
Determination That ORLAAM (Levomethadyl Acetate Hydrochloride) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that ORLAAM (levomethadyl acetate hydrochloride (HCl)) oral solution, 10 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for levomethadyl acetate HCl oral solution, 10 mg/mL, if all other legal and regulatory requirements are met.