FDA

Javadin oral solution approved for hypertension

November 4, 2025

Brand name: Javadin

Generic name: clonidine hydrochloride

Manufacturer: Azurity Pharmaceuticals

Approval date: October 24, 2025

FDA has approved Javadin (clonidine hydrochloride) oral solution, an immediate-release, ready-to-use oral liquid formulation, for the treatment of hypertension in adult patients to lower blood pressure.

By stimulating alpha-adrenoreceptors in the brain stem, clonidine reduces sympathetic outflow from the CNS and decreases peripheral resistance, renal vascular resistance, heart rate, and blood pressure.

According to a manufacturer press release, Javadin is a berry-flavored, clear, colorless oral solution. Each 5 mL delivers 0.1 mg of clonidine (0.02 mg/mL). Javadin may be used alone or in combination with other antihypertensive agents.

Sources:

Javadin (clonidine hydrochloride) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220256s000lbl.pdf Revised October 2025. Accessed November 3, 2025.

Azurity Pharmaceuticals Announces FDA Approval of JAVADIN^TM (clonidine hydrochloride) Oral Solution. [News release]. 2025. https://azurity.com/azurity-pharmaceuticals-announces-fda-approval-of-javadin-clonidine-hydrochloride-oral-solution/