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news.GlaxoSmithKline (GSK) and Merck & Co have received FDA approval for Staxyn (vardenafil HCI), an orally disintegrating tablet indicated for the treatment of erectile dysfunction (ED).
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Merck claimed that Staxyn is available in 10 mg orally disintegrating tablets. Staxyn is not interchangeable with vardenafil 10mg filmcoated tablets (Levitra). Staxyn provides higher systemic exposure compared to vardenafil 10 mg film-coated tablets (Levitra).
The entities said that Staxyn should be taken orally, as needed, approximately 60 minutes before sexual activity. The maximum dosing frequency is one Staxyn tablet per day. Sexual stimulation is required for a response to treatment.
Staxyn disintegrates on the tongue without liquid. The tablet should be taken without liquid. It should be taken immediately upon removal from the blister.
GSK and Merck are expected to market Staxyn in US, under a licensing agreement with Bayer Healthcare Pharmaceuticals and make the medicine available by prescription later this year.