Elestrin Approval History beta

  • FDA approved: Yes (First approved December 15th, 2006)
  • Brand name: Elestrin
  • Generic name: estradiol
  • 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.

FDA Approval History for Elestrin

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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