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FDA Approved Drugs: Changes to Approved Drugs01:26

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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: Ubrogepant: First Approval.

Lesley J Scott1

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

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This summary is machine-generated.

Ubrogepant is now available as an open access publication, allowing for wider dissemination of information. This change facilitates broader access to research on this new migraine treatment.

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Area of Science:

  • Pharmacology
  • Drug Approval

Background:

  • Ubrogepant represents a novel therapeutic option for migraine management.
  • Initial publication was online-first without open access.

Purpose of the Study:

  • To announce the post-publication open access of the Ubrogepant article.
  • To detail the terms under which the article is now available.

Main Methods:

  • Article initially published online-first.
  • Allergan Sales, LLC funded open access conversion.
  • Article distributed under Creative Commons Attribution 4.0 International License.

Main Results:

  • The article "Ubrogepant: First Approval" is now open access.
  • Reprint and reuse are permitted with appropriate credit and license adherence.

Conclusions:

  • Open access enhances the reach of Ubrogepant research.
  • Creative Commons license ensures proper attribution and usage.