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FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...

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Related Experiment Video

Updated: May 12, 2026

A Pipeline to Investigate the Structures and Signaling Pathways of Sphingosine 1-Phosphate Receptors
12:27

A Pipeline to Investigate the Structures and Signaling Pathways of Sphingosine 1-Phosphate Receptors

Published on: June 8, 2022

Ospemifene: first global approval.

Shelley Elkinson1, Lily P H Yang

  • 1Adis R&D Insight, 41 Centorian Drive, Private Bag 65901 Mairangi Bay, North Shore 0754, Auckland, New Zealand. dru@adis.com

Drugs
|April 23, 2013
PubMed
Summary
This summary is machine-generated.

Ospemifene is a novel oral medication offering relief for postmenopausal women experiencing moderate to severe dyspareunia. This selective estrogen receptor modulator provides a non-estrogen treatment option for vulvar and vaginal atrophy symptoms.

Related Experiment Videos

Last Updated: May 12, 2026

A Pipeline to Investigate the Structures and Signaling Pathways of Sphingosine 1-Phosphate Receptors
12:27

A Pipeline to Investigate the Structures and Signaling Pathways of Sphingosine 1-Phosphate Receptors

Published on: June 8, 2022

Area of Science:

  • Pharmacology
  • Gynecology
  • Women's Health

Background:

  • Vulvar and vaginal atrophy (VVA) is a common condition in postmenopausal women.
  • Dyspareunia, or painful intercourse, is a significant symptom of VVA, impacting quality of life.
  • Existing treatments often involve hormone replacement therapy, which may not be suitable for all patients.

Purpose of the Study:

  • To summarize the development milestones of ospemifene.
  • To highlight ospemifene's approval as a non-estrogen treatment for dyspareunia associated with VVA.

Main Methods:

  • Review of global development and regulatory processes for ospemifene.
  • Analysis of clinical data leading to regulatory approval.

Main Results:

  • Ospemifene is the first oral, non-estrogen treatment approved for moderate to severe dyspareunia in women with VVA.
  • Global development was conducted by QuatRx Pharmaceuticals, with Shionogi handling worldwide regulatory filing and commercialization.
  • The drug has received US approval, with EU regulatory submission in progress.

Conclusions:

  • Ospemifene represents a significant advancement in managing dyspareunia related to VVA.
  • This selective estrogen receptor modulator offers a new therapeutic avenue for postmenopausal women.
  • Further regulatory approvals are anticipated in other regions.