Novitium Pharma has received approval from the Food and Drug Administration (FDA) to market Sildenafil for Oral Suspension, 10mg/mL, a generic of Pfizer’s Revatio for oral suspension which is currently listed on the FDA’s drug shortages list. This is the first therapeutically equivalent generic for this product.

“We are pleased to announce that the launch of Sildenafil for Oral Suspension has already initiated,” said Novitium Chief Executive Officer Chad Gassert. “Novitium remains dedicated to providing patients with a steady supply of affordable treatment options, and to progressing the availability of generics in niche therapeutic categories.”

Sildenafil for Oral Suspension is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening.

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Sildenafil for Oral Suspension is supplied as 125mL amber glass bottles for reconstitution. Following reconstitution, the volume of the oral suspension is 112mL (10mg sildenafil/mL). A 2mL oral dosing syringe (with 0.5mL and 2mL dose markings) and a press-in bottle adaptor are also provided.

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