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