Zdrowie i gospodarka · 17/08/2009
Determination That DEMADEX (Torsemide) Injection, 20 Milligrams/2 Milliliter (10 Milligrams/Milliliter) and 50 Milligrams/5 Milliliter (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing its determination that DEMADEX (torsemide) injection, 20 milligrams (mg)/2 milliliter (mL) (10 mg/mL) and 50 mg/5 mL (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness.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 torsemide injection, 20 mg/2mL (10 mg/mL) and 50 mg/5 mL (10 mg/mL), if all other legal and regulatory requirements are met.