NDAORALTABLETPriority Review
Approved
Mar 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
SALAGEN (pilocarpine hydrochloride) by Orasis Pharmaceuticals is clinical pharmacology: pharmacodynamics: pilocarpine is a cholinergic parasympathomimetic agent exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. First approved in 1994.
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SALAGEN is an oral cholinergic parasympathomimetic agent (pilocarpine hydrochloride) approved in 1994 for stimulating salivary and lacrimal gland secretion. It works by acting as a broad-spectrum muscarinic agonist, increasing exocrine gland output including sweat, salivary, lacrimal, gastric, pancreatic, and intestinal secretions. The drug is indicated primarily for xerostomia (dry mouth) in head and neck cancer patients post-radiation and for dry mouth and dry eye symptoms in Sjögren's syndrome patients.
$0.043BPart D
LOE ApproachingDeclining
Mature niche product with declining volume and small market footprint; limited growth opportunity and likely team consolidation ahead.
Mechanism of Action
CLINICAL PHARMACOLOGY: Pharmacodynamics: Pilocarpine is a cholinergic parasympathomimetic agent exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. Pilocarpine, in appropriate dosage, can increase secretion by the exocrine glands. The sweat, salivary, lacrimal,…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.