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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: Pexidartinib: First Approval.

Yvette N Lamb1

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

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Area of Science:

  • Correction of scientific literature.

Background:

  • The original publication contained errors requiring an update.

Purpose of the Study:

  • To provide a corrected version of the original article.

Main Methods:

  • A review and amendment of the original manuscript.

Main Results:

  • The article has been revised to ensure accuracy.

Conclusions:

  • The corrected article is now available for reference.