NDAPERIODONTALFIBER, EXTENDED RELEASE
Approved
Mar 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
ACTISITE (tetracycline hydrochloride) by Pfizer is clinical pharmacology tetracyclines are readily absorbed and are bound to plasma protein in varying degrees. First approved in 1994.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTISITE is a tetracycline hydrochloride fiber formulation delivered as an extended-release periodontal insert for localized treatment of periodontal disease. It works by inhibiting bacterial protein synthesis via binding to the 30S ribosomal subunit, exerting bacteriostatic activity against a broad spectrum of gram-positive and gram-negative organisms including Propionibacterium acnes and periodontal pathogens. The product targets patients with active periodontal pockets requiring adjunctive antimicrobial therapy.
LOE Approaching
Product is in late-stage life cycle with moderate competitive pressure (30), indicating defensive marketing and niche positioning rather than growth-phase expansion opportunities.
Mechanism of Action
CLINICAL PHARMACOLOGY Tetracyclines are readily absorbed and are bound to plasma protein in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. Microbiology Tetracyclines are primarily…
Indications
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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.