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SCE-A Approval History

  • FDA approved: Yes (First approved November 28th, 2008)
  • Brand name: SCE-A
  • Generic name: Synthetic Conjugated Estrogens-A
  • Dosage form: Vaginal Cream
  • Previous name: Bijuva
  • Company: Duramed Pharmaceuticals, Inc.
  • Treatment for: Postmenopausal Symptoms

SCE-A (synthetic conjugated estrogens, A) Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause.

Development History and FDA Approval Process for SCE-A

DateArticle
Dec  1, 2008Approval FDA Approves Duramed's Synthetic Conjugated Estrogens-A Vaginal Cream
Apr 26, 2005Barr's Receives Not Approvable Letter for Bijuva Vaginal Cream

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