Qnexa Proposed REMS Focuses On Registry, Web-Based Physician Education
This article was originally published in The Pink Sheet Daily
FDA advisory committee will hear Vivus' proposal for a voluntary pregnancy registry that could calculate the risk of major birth defects from the obesity drug; potential cardiovascular problems would be assessed in large outcomes trial.
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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.
A Risk Evaluation and Mitigation Strategy for Qsymia includes prescriber education about the risk of birth defects and limits dispensing to specially certified pharmacies
The biotech once again submits its application to FDA for its obesity drug, but the upside potential is drastically cut.