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Withdrawal of Approval of a New Drug Application; Determination That Doxycycline Hyclate 20-Milligram Capsules Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

摘要

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(doxycycline hyclate) 20- milligram (mg) capsules were no longer marketed and requested that approval of NDA 50-774 be withdrawn. FDA has determined that PERIOSTAT (doxycycline hyclate) 20-mg capsules were not withdrawn from sale for reasons of safety or effectiveness.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.