1. Pink Sheet

REMS For Qsymia Limits Distribution, But Vivus To Explore Expanding Access

 
• By Cathy Dombrowski

Qsymia will launch through certified mail-order pharmacies, but FDA has asked the sponsor to look for ways to expand into the retail space with pharmacies that can meet requirements for distributing patient risk information and keeping track of prescribers.

Vivus Inc. will distribute its obesity drug Qsymia only through select mail-order pharmacies at launch, but, at FDA’s request, will expand to retail pharmacies as soon as the company can develop a plan to do so.

FDA approved Qsymia, a combination of phentermine and extended-release topiramate and formerly known as Qnexa, July 17 with a Risk Evaluation and Mitigation Strategy to address the risk of birth defects in infants exposed to the drug during the first trimester of pregnancy (see related storyAlso see "Qsymia Sales Reps Recruited For Experience With Metabolic Products" -

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