NDAORALCAPSULE
Approved
Dec 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
SECTRAL (acebutolol hydrochloride) by ANI Pharmaceuticals is clinical pharmacology acebutolol is a cardioselective, β-adrenoreceptor blocking agent, which possesses mild intrinsic sympathomimetic activity (isa) in its therapeutically effective dose range. Approved for hypertension in adults, the management of ventricular premature beats, hypertension and 1 more indications. First approved in 1984.
Drug data last refreshed 9h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Sectral is a cardioselective beta-1 adrenergic receptor blocking agent with intrinsic sympathomimetic activity (ISA) approved for hypertension and ventricular premature beats. It reduces heart rate, cardiac output, and blood pressure through beta-blockade while maintaining relative selectivity for cardiac tissue over bronchial and vascular beta-2 receptors. The ISA property distinguishes it from non-selective beta-blockers by producing smaller reductions in resting heart rate.
LOE Approaching
Product approaching loss of exclusivity with declining market relevance; ANI Pharmaceuticals team likely focused on generic optimization and cost-containment rather than expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Acebutolol is a cardioselective, β-adrenoreceptor blocking agent, which possesses mild intrinsic sympathomimetic activity (ISA) in its therapeutically effective dose range. Pharmacodynamics β 1 -cardioselectivity has been demonstrated in experimental animal studies. In…
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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.