Watson gains FDA approval for generic Revatio

12 November 2012

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application for sildenafil,  the generic equivalent to global pharma behemoth Pfizer's (NYSE: PFE) Revatio.

Watson says it intends to begin shipping the product in the near future. Revatio, which uses the same active ingredient as Pfizer’s erectile dysfunction drug Viagra, is indicated for the treatment of pulmonary arterial hypertension (PAH) in adults to improve exercise ability and delay clinical worsening.

For the 12 months ending September 30, 2012, Revatio tablets 20mg had total US sales of around $339 million according to IMS Health data, quoted by Watson.

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