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01/05/2023

Aurobindo receives FDA approval for 3 generics

The company received approval for solifenacin succinate tablets, ranolazine extended-release tablets and sildenafil for oral suspension.
Gisselle Gaitan
Online Editor
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Aurobindo Pharma Limited said the United States Food and Drug Administration has granted it approval for its abbreviated new drug application for solifenacin succinate tablets in 5 mg and 10 mg.

The solifenacin succinate tablets are an AB-rated generic equivalent to VESIcare tablets, and are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency,

A second approval was granted for the company's ranolazine extended-release tablets in 500 mg and 100 mg strengths.

[Read more: Aurobindo obtains FDA OK for 2 generics]

Ranolazine extended-release tablets are an AB-rated generic equivalent to Ranexa, and are indicated for the treatment of chronic angina.

Lastly, Aurobindo received approval for sildenafil for oral suspension in 10 mg/ML, a generic equivalent to Revatio.

Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension in adults to improve exercise ability and delay clinical worsening.

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