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Elestrin Approval History

  • FDA approved: Yes (First approved December 15th, 2006)
  • Brand name: Elestrin
  • Generic name: estradiol
  • Dosage form: Gel
  • Previous name: Bio-E-Gel
  • Company: BioSante Pharmaceuticals, Inc.
  • Treatment for: Postmenopausal Symptoms

Elestrin is a fast-drying transdermal gel formulation of bio-identical estradiol indicated for the treatment of moderate-to-severe vasomotor symptoms (hot flashes) associated with menopause.

Development History and FDA Approval Process for Elestrin

Dec 18, 2006Approval Elestrin BioSante Pharmaceuticals, Inc. - Treatment for Menopausal Vasomotor Symptoms
Apr 19, 2006BioSante Pharmaceuticals Announces FDA Filing and Review of NDA for Bio-E-Gel
Feb 16, 2006BioSante Pharmaceuticals Announces Bio-E-Gel NDA Submission

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