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A Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 (minocycline HCl) Extended Release Capsules Compared to Placebo for the Treatment of Inflammatory Lesions of Rosacea over 16 weeks

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Trial Profile

A Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of Oral DFD-29 (minocycline HCl) Extended Release Capsules Compared to Placebo for the Treatment of Inflammatory Lesions of Rosacea over 16 weeks

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 02 Apr 2024

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At a glance

  • Drugs Minocycline (Primary)
  • Indications Erythema; Rosacea
  • Focus Therapeutic Use
  • Sponsors Dr Reddys Laboratories

    • Most Recent Events

    • 28 Mar 2024 According to a Fortress Biotech media release, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) filing for DFD-29 earlier this month and look forward to the Prescription Drug User Fee Act (PDUFA) goal date of November 4, 2024.
    • 02 Jan 2024 According to a Journey Medical Corporation media release,company a has entered into a credit facility with an affiliate of SWK Holdings Corporation a specialized finance company with a focus on the global healthcare sector, providing for borrowings of up to $20 million and this The funding will support general corporate purposes, as well as anticipated expenses for DFD-29, including an upcoming New Drug Application submission pending FDA approval.
    • 30 Mar 2023 According to a Fortress Biotech media release, an FDA approval decision is anticipated in the second half of 2024.

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