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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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Correction to: Ibalizumab: First Global Approval.

Anthony Markham1

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

Drugs
|May 31, 2018
PubMed
Summary

Ibalizumab has received its first global approval, marking a significant advancement in treatment options. This novel therapy offers new hope for patients awaiting effective interventions.

Area of Science:

  • Pharmacology
  • Immunology
  • Drug Development

Background:

  • Ibalizumab is a novel therapeutic agent targeting specific immune pathways.
  • The development of new treatments for complex diseases remains a critical area of research.

Purpose of the Study:

  • To report the first global regulatory approval of Ibalizumab.
  • To provide an overview of the drug's significance and potential impact.

Main Methods:

  • Review of regulatory submission data.
  • Analysis of clinical trial outcomes (details not provided in abstract).
  • Pharmacological profiling of Ibalizumab.

Main Results:

  • Ibalizumab has achieved its initial global marketing authorization.

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  • The approval signifies a milestone in the drug's journey from development to clinical use.
  • Conclusions:

    • The first global approval of Ibalizumab represents a significant therapeutic breakthrough.
    • Further research and clinical application will define its role in patient care.