Granules India subsidiary bags USFDA nod for Sildenafil for Oral Suspension
Sildenafil for Oral Suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening.;
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Hyderabad: Granules India Limited has recently announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA), filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the company, for Sildenafil for Oral Suspension, 10 mg/mL.
It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Revatio for Oral Suspension, 10mg/ml, of Viatris Specialty LLC.
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