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🏅 FDA Orphan Designation

Sildenafil

SILDENAFIL POWDER,

Manufacturer: Camber Pharmaceuticals, Inc.

Indicated for:
Idiopathic/heritable pulmonary arterial hypertensionOrphanPulmonary arterial hypertension

FDA-Approved Indications (2)

treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in pediatric patients 1 to 17 years old to improve exercise ability and, in pediatric patients too young to perform standardized exerci…

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

Population: adults

Indications & Usage

1 INDICATIONS AND USAGE Adults Sildenafilfororal 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 [ see Clinical Studies (14 )] . Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) for oral suspension. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. Adults Sildenafil for oral suspension is a phosphodiesterase-5 (PDE-5) inhibitor 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. (1 )

Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.