Zdrowie i gospodarka · 30.08.2011
Determination That OPANA ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 7.5 Milligrams and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that OPANA ER (oxymorphone hydrochloride (HCl)) extended-release tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs for oxymorphone HCl extended- release tablets, 7.5 mg and 15 mg, if all other legal and regulatory requirements are met.