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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Trifarotene: First Approval.

Lesley J Scott1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|November 13, 2019
PubMed
Summary
This summary is machine-generated.

Topical trifarotene, a novel selective retinoic acid receptor-γ agonist, has been developed for acne vulgaris treatment. It received its first global approval in the USA in October 2019 for patients aged 9 and older.

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Area of Science:

  • Dermatology
  • Pharmacology

Background:

  • Acne vulgaris is a common skin condition.
  • Retinoids are a cornerstone of acne treatment.
  • Trifarotene is a novel topical retinoid targeting the retinoic acid receptor-gamma (RAR-γ).

Purpose of the Study:

  • To summarize the development milestones of trifarotene.
  • To highlight the path to its first global approval for acne vulgaris.

Main Methods:

  • Review of development history and regulatory submissions.
  • Analysis of preclinical and clinical data supporting efficacy and safety.

Main Results:

  • Trifarotene is a first-in-class topical retinoid.
  • Selective RAR-γ agonism differentiates it from other retinoids.
  • Received first global approval in the USA in October 2019.

Conclusions:

  • Trifarotene represents a significant advancement in topical acne treatment.
  • Its development milestones culminated in a key regulatory approval.
  • Offers a new therapeutic option for acne vulgaris.