ROBERTS PHARMACEUTICAL PRO-BANTHINE NDA FOR URINARY INCONTINENCE
ROBERTS PHARMACEUTICAL PRO-BANTHINE NDA FOR URINARY INCONTINENCE, filed in early December, is constructed entirely of available literature; Roberts did not conduct prospective clinical trials to support the filing, the company said. After acquiring Pro-banthine (propantheline) from Searle in December 1992, Roberts undertook a review of the published studies and determined that the additional indication was "both appropriate and justified" based on the available clinical trial data. The studies were subsequently "compiled, summarized and presented in NDA format," the company said. Pro-banthine tablets are currently marketed as an adjunctive therapy for treatment of peptic ulcers and are widely available in generic form.
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