TheraRadar
Data updated: May 26, 2026

POLOCAINE-MPF (mepivacaine hydrochloride)

Other Approved 1986-12-01

POLOCAINE-MPF is indicated for the treatment of Analgesia; Anesthesia.

Source: FDA Label • Fresenius Kabi
1
Indication
--
Phase 3 Trials
39
Years on Market

Details

Status
Prescription
First Approved
1986-12-01
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: MEPIVACAINE HYDROCHLORIDE

POLOCAINE-MPF Approval History

1987
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2026
Original
New Indication
New Form
Label Update
39 FDA actions from 1986 to 2025
Jan 2025 SUPPL
Label · Labeling
Jun 2010 SUPPL
Label · Labeling
May 2002 SUPPL
Label · Labeling

What POLOCAINE-MPF Treats

2 indications

POLOCAINE-MPF is approved for 2 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Analgesia
  • Anesthesia
Source: FDA Label

POLOCAINE-MPF Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to POLOCAINE-MPF

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BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
BUPIVACAINE HYDROCHLORIDE
2 shared
Pfizer
Shared indications:
AnesthesiaAnalgesia
MARCAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE
2 shared
Pfizer
Shared indications:
AnesthesiaAnalgesia
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
BUPIVACAINE HYDROCHLORIDE
2 shared
Pfizer
Shared indications:
AnesthesiaAnalgesia
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Active Pipeline

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Key Completed Trials

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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.

POLOCAINE-MPF FDA Label Details

Indications & Usage

POLOCAINE-MPF is indicated for the treatment of Analgesia; Anesthesia.

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Data Sources

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