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Emrosi FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 5, 2024.

FDA Approved: Yes (First approved November 1, 2024)
Brand name: Emrosi
Generic name: minocycline hydrochloride
Dosage form: Extended-Release Capsules
Previous Name: DFD-29
Company: Journey Medical Corporation
Treatment for: Rosacea

Emrosi (minocycline hydrochloride) is a low-dose, modified-release capsule formulation of the approved tetracycline-class drug minocycline indicated to treat the inflammatory lesions of rosacea in adults.

Development timeline for Emrosi

DateArticle
Nov  4, 2024Approval FDA Approves Emrosi (minocycline hydrochloride) for the Treatment of Rosacea
Mar 18, 2024Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea
Jan  5, 2024Journey Medical Corporation Submits New Drug Application to FDA for DFD-29 to Treat Rosacea
Oct 20, 2023Journey Medical Corporation Announces Data from Bioavailability Study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) vs. Solodyn® (Minocycline Hydrochloride Extended-Release Tablets, 105 mg)
Jul 11, 2023Journey Medical Corporation Announces Positive Topline Results from its Two Phase 3 Clinical Trials (MVOR-1 and MVOR-2) Evaluating DFD-29 for the Treatment of Papulopustular Rosacea in Adults

Further information

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