Rowasa (Mesalamine) - Summary

ROWASA SUMMARY

The active ingredient in ROWASA® (Mesalamine) Rectal Suspension Enema, a disposable (60 mL) unit, is mesalamine, also known as 5-aminosalicylic acid (5-ASA).

ROWASA® (Mesalamine) Rectal Suspension Enema is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.

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ROWASA NEWS HIGHLIGHTS

Media Articles Related to Rowasa (Mesalamine)

Mesalamine Granules Maintain Remission In Ulcerative Colitis Patients Who Switch From Another 5-ASA
Source: Irritable-Bowel Syndrome News From Medical News Today [2008.10.08]

APRISO(TM) Granted FDA Marketing Approval For Maintenance Of Remission Of Ulcerative Colitis
Source: Irritable-Bowel Syndrome News From Medical News Today [2008.11.04]

APRISO™ Granted FDA Marketing Approval For Maintenance Of Remission Of Ulcerative Colitis
Source: Irritable-Bowel Syndrome News From Medical News Today [2008.11.03]

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Published Studies Related to Rowasa (Mesalamine)

Erythrocyte-mediated delivery of dexamethasone in patients with mild-to-moderate ulcerative colitis, refractory to mesalamine: a randomized, controlled study. [2008.10]

Delayed-release oral mesalamine 4.8 g/day (800 mg tablets) compared to 2.4 g/day (400 mg tablets) for the treatment of mildly to moderately active ulcerative colitis: The ASCEND I trial. [2007.12]

Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. [2007.01]

Delayed-release oral mesalamine at 4.8 g/day (800 mg tablet) for the treatment of moderately active ulcerative colitis: the ASCEND II trial. [2005.11]

Efficacy and safety of mesalamine 1 g HS versus 500 mg BID suppositories in mild to moderate ulcerative proctitis: a multicenter randomized study. [2005.07]

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Clinical Trials Related to Rowasa (Mesalamine)

Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I) [Completed]

A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease [Completed]

Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis [Completed]

Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis [Terminated]

A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis. [Completed]

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