Aurobindo Receives FDA Approval for Propafenone Hydrochloride Extended-Release Capsules USP, 225 mg, 325 mg, and 425 mg
Published: February 21, 2023
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Propafenone Hydrochloride Extended-Release Capsules USP, 225 mg, 325 mg, and 425 mg. Aurobindo Pharma’s Propafenone Hydrochloride Extended-Release Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), RYTHMOL SR® Capsules manufactured by GlaxoSmithKline.
Propafenone Hydrochloride Extended-Release Capsules are indicated to:
- Prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.
