Lupin 2023

Aurobindo gets thumbs up from FDA for sildenafil for oral suspension

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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 sildenafil for oralsuspension, 10mg/mL. Aurobindo Pharma’s sildenafil for oral suspension, are an AB-rated generic equivalent to the reference listed drug (RLD), Revatio for oral suspension 10mg/mL manufactured by Viatris Specialty LLC.

Sildenafil for oral suspension, are indicated for treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening.

Sildenafil for oral suspension, has an estimated market size of US $59.8 Million for the twelve months ending October 2022, as per IQVIA.

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