Zdrowie i gospodarka · 18/04/2013

FDA Withdraws OXYCONTIN Extended-Release Tablets from Sale Due to Safety or Effectiveness Concerns

The FDA has withdrawn OXYCONTIN extended-release tablets from sale due to safety or effectiveness concerns, and will not accept new applications referencing NDA 20-553. The agency made this determination for the 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg, and 160mg formulations approved under NDA 20-553.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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