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Data updated: Mar 10, 2026

PITOCIN

OXYTOCIN
Metabolic Approved 1980-11-19
1
Indication
--
Phase 3 Trials
45
Years on Market

Details

Status
Prescription
First Approved
1980-11-19
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: OXYTOCIN

PITOCIN Approval History

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What PITOCIN Treats

7 indications

PITOCIN is approved for 7 conditions since its original approval in 1980. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Diabetes
  • Preeclampsia
  • Premature Rupture of Membranes
  • Uterine Inertia
  • Incomplete Abortion
  • Inevitable Abortion
  • Postpartum Hemorrhage
Source: FDA Label

PITOCIN Boxed Warning

IMPORTANT NOTICE Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor....

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PITOCIN FDA Label Details

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Indications & Usage

FDA Label (PDF)

IMPORTANT NOTICE Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor. Antepartum: Pitocin is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable for reasons of fetal or maternal concern, in order to achieve vaginal delivery. It is indicated for induction of labor in patients with a medical indication f...

โš ๏ธ BOXED WARNING

IMPORTANT NOTICE Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor...

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.