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Imprese · 16/05/20051 min di lettura
CollaGenex Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application; Determination That Doxycycline Hyclate 20-Milligram Capsules Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Riepilogo
The Food and Drug Administration (FDA) is withdrawing approval of one new drug application (NDA). CollaGenex Pharmaceuticals, Inc., notified the agency in writing that PERIOSTAT (doxycycline hyclate) 20- milligram (mg) capsules were no longer marketed and requested that approval of NDA 50-774 be withdrawn. FDA has determined that PERIOSTAT (doxycycline hyclate) 20-mg capsules were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for doxycycline hyclate 20-mg capsules.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →