FDA grants approval for first generic version of Viagra
pharmafile | March 10, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | FDA, Pfizer, Teva, erectile dysfunction, generic, viagra
The US Food and Drug Administration (FDA) has granted approval to the first generic version of Pfizer’s blockbuster erectile dysfunction drug, Viagra (sildenafil citrate).
Israeli-based Teva Pharmaceuticals has received the approval, but have also agreed a deal with Pfizer to delay bringing the generic to market until December 2017. Reuters reported a similar deal struck between Pfizer and Mylan, with the latter’s generic still subject to FDA approval.
Teva has gained approval for the drug at 25mg, 50mg and 100mg doses. It previously launched its Viagra generic in the EU in 2013.
Teva will pay royalties through to the expiration of the Viagra patent in the US in April 2020.
Sean Murray
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