Elestrin FDA Approval History
FDA Approved: Yes (First approved December 15, 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 timeline for Elestrin
| Date | Article |
|---|---|
| Dec 18, 2006 | Approval Elestrin BioSante Pharmaceuticals, Inc. - Treatment for Menopausal Vasomotor Symptoms |
| Apr 19, 2006 | BioSante Pharmaceuticals Announces FDA Filing and Review of NDA for Bio-E-Gel |
| Feb 16, 2006 | BioSante Pharmaceuticals Announces Bio-E-Gel NDA Submission |
Further information
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