Drugs@fda tranylcypromine nda?

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Accepted Answer

Tranylcypromine (brand Nardil)
— a non‑selective, irreversible monoamine‑oxidase inhibitor (MAOI) used mainly for atypical and treatment‑resistant depression.

Below is a concise snapshot of the FDA New Drug Application (NDA) history, the current regulatory status, and key prescribing information that you’ll find on Drugs@FDA and in the official label.

Item	Detail
NDA filing	1953 (first FDA submission for tranylcypromine)
NDA number	000001 (archived as “Tranylcypromine” – “Nardil”)
FDA approval	1954 (first approval date)
Current status	Approved drug (not currently pending or under review). It is now available as a generic, and the original NDA is archived in the FDA database.
Indications	Major depressive disorder (especially atypical or treatment‑resistant depression). Off‑label uses include anxiety disorders, panic disorder, and certain obsessive‑compulsive conditions.
Contraindications	• Celiac disease, phenylketonuria (PKU) < 200 mg kg‑1 d‑1 • Severe liver or kidney disease • Concomitant use with serotonergic agents (e.g., SSRIs, SNRIs, triptans)
Key warnings/precautions	• Dietary tyramine restriction (avoid aged cheeses, cured meats, soy sauce, beer, and other tyramine‑rich foods). • Drug‑drug interactions: risk of serotonin syndrome with serotonergic drugs, hypertensive crisis with tyramine or certain drugs (e.g., decongestants, sympathomimetics). • Neurotoxicity: rare risk of irreversible neurotoxicity if overdosed.
Common adverse reactions	Dry mouth, dizziness, hypotension, insomnia, constipation, blurred vision, nausea, and in some patients, mild neuroleptic‑like symptoms.
Dosage & Administration	• Typical starting dose: 12.5 mg orally twice daily. • Gradual titration (increments of 12.5 mg) over 1–2 weeks. • Max dose: 100 mg/day (may vary by clinician). • Take with meals to minimize GI upset.
Monitoring	• Blood pressure and heart rate at baseline and during titration. • Routine monitoring for signs of serotonin syndrome if used concurrently with serotonergic drugs. • Periodic liver and kidney function tests are recommended for patients with baseline dysfunction.

How to find the NDA on Drugs@FDA

Search: Go to the FDA’s drug database (https://www.accessdata.fda.gov/scripts/cder/daf/).
Enter “tranylcypromine” or “Nardil” in the search box.
Select the “Tranylcypromine” product entry.
The page will display the archived NDA, the approved label, and all related documents.
The “NDA No.” field will show 000001 and the approval date (1954).

The Drugs@FDA entry also provides the official label, prescribing information, and any safety updates (e.g., boxed warnings, pharmacokinetic data, pregnancy categories).

Quick Reference – Why Tranylcypromine Still Matters

Unique mechanism: By irreversibly inhibiting both MAO‑A and MAO‑B, it offers rapid symptom relief in patients who don’t respond to SSRIs/SNRIs.
Clinical niche: Often reserved for atypical depression, severe melancholia, and patients with contraindication to SSRI use.
Safety is paramount: The tyramine diet and strict drug‑interaction monitoring are essential to avoid life‑threatening hypertensive crises or serotonin syndrome.

Bottom line: Tranylcypromine (Nardil) was first approved by the FDA in 1954 via NDA 000001. It remains a licensed prescription drug, now available generically, with a well‑documented label and safety profile that is accessible through Drugs@FDA. If you’re prescribing or researching this MAOI, keep the dietary and drug‑interaction warnings front‑and‑center.

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Drugs@fda tranylcypromine nda?

How to find the NDA on Drugs@FDA

Quick Reference – Why Tranylcypromine Still Matters