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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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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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Prescription, Nonprescription and Orphan Drugs01:02

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Related Experiment Video

Updated: Nov 2, 2025

Automated Preparation of [68Ga]Ga-3BP-3940 on a Synthesis Module for PET Imaging of the Tumor Microenvironment
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Fuzuloparib: First Approval.

Arnold Lee1

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

Drugs
|June 12, 2021
PubMed
Summary

Fuzuloparib is a new oral PARP inhibitor approved in China for ovarian, fallopian tube, and peritoneal cancers. It targets patients with germline BRCA mutations who have received prior chemotherapy.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Fuzuloparib is an orally active PARP inhibitor developed for solid cancers.
  • Jiangsu Hengrui Pharmaceuticals is the developer of this small molecule drug.

Purpose of the Study:

  • To summarize the development milestones of fuzuloparib.
  • To highlight its first approval for specific gynecological cancers in China.

Main Methods:

  • Review of development and clinical trial data for fuzuloparib.
  • Focus on its approval for platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer.

Main Results:

  • Fuzuloparib received approval in China.
  • The approval is for patients with germline BRCA mutations undergoing second-line or later chemotherapy.

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Conclusions:

  • Fuzuloparib represents a significant advancement in treating specific gynecological cancers.
  • The drug's development milestones led to its initial regulatory success.