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Reliant Pharmaceuticals, Liberty Corner, NJ. Sept. 14 (DDMAC).

Publication: Warning Letter Bulletin
Publication Date: 01-OCT-06 		Format: Online
Delivery: Immediate Online Access
Full Article Title: Reliant Pharmaceuticals, Liberty Corner, NJ. Sept. 14 (DDMAC).(HUMAN DRUGS & DIETARY SUPPLEMENTS)

Article Excerpt
DDMAC reviewed two of Reliant's promotional pieces, identified as RYTH-2026 and RYTH-1028, for Rythmol SR (propafenone HCl) extended-release capsules and determined the promotional pieces to be false and misleading because they failed to communicate serious risk information for Rythmol SR but broadened the indication for the product.

According to the Indications and Usage section of the FDA-approved PI for Rythmol SR, the product is indicated to prolong the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease....

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