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Aurobindo gets FDA approval for propafenone hydrochloride ER capsules

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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Aurobindo Receives FDA Approval for propafenone hydrochloride ER capsules USP, 225mg, 325mg, and 425mg. Aurobindo Pharma’s propafenone hydrochloride ER capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), RYTHMOL SR Capsules manufactured by GlaxoSmithKline.

Propafenone hydrochloride ER 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.

Propafenone hydrochloride ER capsules, has an estimated market size of US $18.4 Million for the twelve months ending February 2023, as per IQVIA.


ECRM_06-01-22


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