Tentative FDA appro for Teva's Requip
The US Food and Drug Administration has granted tentative approval for Israeli drugmaker Teva Pharmaceutical Industries' Abbreviated New Drug Application to market its generic version of world number two pharmaceutical company GlaxoSmithKline's Requip (ropinirole HCl) tablets, 0.25mg base, 0.5mg base, 1mg base, 2mg base, 3mg base, 4mg base and 5mg base. Final approval is expected upon expiry of patent protection for the brand product on May 19, 2008.
At that time, Teva's product will be the AB-rated generic equivalent of Requip, and will be indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease as well as treatment of moderate to severe primary restless leg syndrome.
The brand product had annual sales of around $455.0 million in the USA for the12 months ended September 30, 2007, based on IMS Health sales data.
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