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Angeliq Approval History

  • FDA approved: Yes (First approved September 28th, 2005)
  • Brand name: Angeliq
  • Generic name: drospirenone and estradiol
  • Dosage form: Tablets
  • Company: Berlex, Inc.
  • Treatment for: Postmenopausal Symptoms

Angeliq is a hormone replacement therapy containing estradiol and the progestin drospirenone, a hormone that counters the excess water and sodium buildup that is a side effect of estradiol. Angeliq is used to treat moderate to severe menopausal symptoms, such as hot flashes and vaginal dryness.

Development History and FDA Approval Process for Angeliq

Feb 29, 2012Approval U.S. FDA Approves Lower Dose Formulation of Angeliq (drospirenone and estradiol) Tablets
Sep 28, 2005Approval Angeliq Berlex, Inc. - Treatment for Menopausal Symptoms
Sep 15, 2004FDA Issues Approvable Letter to Berlex Laboratories for Angeliq

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