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Intrarosa Approval History

Reviewed on Nov 17, 2016 by J.Stewart BPharm
  • FDA approved: Yes (First approved November 17th, 2016)
  • Brand name: Intrarosa
  • Generic name: prasterone
  • Dosage form: Vaginal Inserts
  • Company: Endoceutics Inc.
  • Treatment for: Dyspareunia

Intrarosa (prasterone) is a once-daily, vaginally administered steroid indicated to treat postmenopausal women experiencing moderate to severe pain during sexual intercourse (dyspareunia) as a symptom of vulvar and vaginal atrophy.

Efficacy of Intrarosa was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women. Intrarosa was shown to reduce the severity of pain experienced during sexual intercourse when compared to placebo.

Intrarosa inserts are administered vaginally with a single-use applicator once daily at bedtime. Common side effects reported in clinical studies include vaginal discharge and abnormal Pap smear results.

Development History and FDA Approval Process for Intrarosa

Nov 17, 2016Approval FDA Approves Intrarosa (prasterone) for Postmenopausal Women Experiencing Dyspareunia

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