TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

LINCOCIN

LINCOMYCIN HYDROCHLORIDE
Infectious Disease Approved 1964-12-29
1
Indication
--
Phase 3 Trials
61
Years on Market

Details

Status
Prescription
First Approved
1964-12-29
Routes
INJECTION, ORAL
Dosage Forms
INJECTABLE, CAPSULE

LINCOCIN Approval History

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What LINCOCIN Treats

3 indications

LINCOCIN is approved for 3 conditions since its original approval in 1964. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Streptococcal Infections
  • Pneumococcal Infections
  • Staphylococcal Infections
Source: FDA Label

LINCOCIN Boxed Warning

WARNING Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including LINCOCIN and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Because lincomycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappr...

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Ongoing clinical trials by development phase

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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.

LINCOCIN FDA Label Details

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Indications & Usage

FDA Label (PDF)

LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING , before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. LINCOCIN may be adminis...

โš ๏ธ BOXED WARNING

WARNING Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including LINCOCIN and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth ...

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Data Sources

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