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Rhofade Approval History

Reviewed on Jan 18, 2017 by J.Stewart BPharm
  • FDA approved: Yes (First approved January 18th, 2017)
  • Brand name: Rhofade
  • Generic name: oxymetazoline hydrochloride
  • Dosage form: Cream
  • Company: Allergan, Inc.
  • Treatment for: Rosacea

Rhofade (oxymetazoline hydrochloride) is a topical alpha1A adrenoceptor agonist vasoconstrictor for the treatment of persistent facial erythema associated with rosacea in adults.

FDA approval of Rhofade was based on the results of two randomized, vehicle-controlled clinical trials of 885 adult patients with moderate or severe rosacea. Rhofade was proven more effective than vehicle in reducing facial erythema associated with rosacea through 12 hours.

Rhofade is a topical cream applied once daily in a thin layer to the entire face, avoiding the eyes and lips. The most common side effects include dermatitis, worsening of rosacea, and itching, swelling and pain at the application site.

Development History and FDA Approval Process for Rhofade

Jan 19, 2017Approval Allergan Announces FDA Approval of Rhofade (oxymetazoline hydrochloride) Cream for Facial Erythema Associated with Rosacea
May 24, 2016Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%

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