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.