REGLAN
Details
- Status
- Prescription
- First Approved
- 1979-02-07
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, SOLUTION, INJECTABLE
REGLAN Approval History
What REGLAN Treats
9 FDA approvalsOriginally approved for its first indication in 1979 . Covers 9 distinct patient populations.
- Other (9)
Other
(9 approvals)- • Approved indication (Feb 1979) Priority
- • Approved indication (Dec 1980)
- • Approved indication (Jan 1981)
- • Approved indication (Feb 1982)
- • Approved indication (Jun 1982)
- • Approved indication (Mar 1983)
- • Approved indication (Jul 1983)
- • Approved indication (Aug 1984)
- • Approved indication (May 1987)
REGLAN Boxed Warning
TARDIVE DYSKINESIA • Metoclopramide, including Reglan, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including Reglan, the risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions ( 5.1 )] . • Reglan is contraindicated in patients with a history of TD. • Use Reglan for the shortest duration of treatment and periodically reassess the need for continued tr...
WARNING: TARDIVE DYSKINESIA • Metoclopramide, including Reglan, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including Reglan, the risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions ( 5.1 )] . • Reglan is contraindicated in patients with a history of TD. • Use Reglan for the shortest duration of treatment and periodically reassess the need for continued treatment. • Immediately discontinue Reglan in patients who develop signs or symptoms of TD [see Warnings and Precautions ( 5.1 )] . • In patients with symptomatic, documented gastroesophageal reflux, the maximum duration of Reglan treatment is 12 weeks [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.1 )] . • In patients with diabetic gastroparesis, avoid a total duration of treatment with metoclopramide products, including Reglan tablets, for longer than 12 weeks. If longer term use is unavoidable, routinely monitor for signs and symptoms of TD [see Warnings and Precautions ( 5.1 )] . WARNING: TARDIVE DYSKINESIA See full prescribing information for complete boxed warning. • Metoclopramide, including Reglan, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder In patients treated with metoclopramide, including Reglan, the risk of developing TD increases with duration of metoclopramide treatment and total cumulative metoclopramide dosage. ( 5.1 ) • Reglan is contraindicated in patients with a history of TD. ( 4 ) • Use Reglan for the shortest duration of treatment and periodically reassess the need for continued treatment. ( 2.1 , 2.2 , 5.1 ) • Immediately discontinue Reglan in patients who develop signs or symptoms of TD. ( 5.1 ) • In patients with symptomatic, documented gastroesophageal reflux, the maximum duration of treatment is 12 weeks. ( 2.1 , 5.1 ) • In patients with diabetic gastroparesis, avoid a tota
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
REGLAN FDA Label Details
ProIndications & Usage
FDA Label (PDF)Reglan tablets are indicated for the: • Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy. • Relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Limitations of Use : • Reglan has not been shown to be safe and effective for the treatment of symptomatic, documented gastroesophageal reflux for longer than 12 weeks [see Warnings and Precautions ] . • Reglan tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramida...
WARNING: TARDIVE DYSKINESIA • Metoclopramide, including Reglan, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including Reglan, the risk of developing TD increases with duration of treatment and total cumulative dosa...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.