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The Pharmaceutical Journal Vol 265 No 7104 p42
July 8, 2000 Clinical

Licence application for impotence drug withdrawn

A US licence application for apomorphine tablets (Uprima) for erectile dysfunction has been withdrawn by the manufacturer, TAP Pharmaceutical Products Inc. TAP is a joint venture between Abbott Laboratories, US, and Takeda Chemical Industries, Japan. Abbott said in a press release on June 30 that TAP had withdrawn the application because of ongoing studies "that could further establish the drug's safety and efficacy profile". It added that the application would be resubmitted to the Food and Drug Administration at a later date. In April, the FDA Advisory Committee had voiced concerns over the safety profile of Uprima noting "potentially life-threatening" risks of treatment - specifically syncope and severe hypotension.