NDAOPHTHALMICSOLUTION/DROPS
Approved
Dec 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
5/8 — Partial
BETADINE (povidone-iodine) by Alcon is clinical pharmacology: a placebo-controlled study in 38 normal volunteers yielded data for 36 subjects who showed a mean log10 reduction of 3. First approved in 1986.
Drug data last refreshed 2d ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BETADINE (povidone-iodine) 5% is a topical antiseptic ophthalmic solution used for preoperative skin preparation in ophthalmic surgery. It works by releasing iodine, which rapidly reduces bacterial colonization on the eye surface, with clinical data showing a 1.47–1.79 log10 reduction in aerobic bacteria versus vehicle control. The product addresses infection prevention in sterile ophthalmic procedures.
$0.001BPart D
LOE ApproachingDeclining
As LOE approaches, the brand team is contracting; focus shifts from growth initiatives to lifecycle extension and competitive defense in a consolidated ophthalmic prep market.
Mechanism of Action
CLINICAL PHARMACOLOGY: A placebo-controlled study in 38 normal volunteers yielded data for 36 subjects who showed a mean log10 reduction of 3.05 log10 units in total aerobes at 10 minutes following prepping the skin with BETADINE* 5% Sterile Ophthalmic Prep Solution compared with reduction of 1.58…
Pharmacologic Class:
Antiseptic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty
Started Jun 2023
60 enrolled
SurgerySurgical Site InfectionCutibacterium Acnes+1 more
Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo
Started Mar 2017
219 enrolled
Adenoviral Conjunctivitis
Betadine Irrigation in Cesarean Section
Started Sep 2015
80 enrolled
Infection; Cesarean Section
Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin
Started Mar 2011
1,874 enrolled
Surgical Site Infection
Povidone-iodine Antisepsis for Strabismus Surgery
Started Sep 2009
70 enrolled
StrabismusSurgeryEndophthalmitis
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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.