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FDAnews Drug Daily Bulletin
July 30, 2012 | Vol. 9 No. 148
Analysts Predict Vivus Obesity Drug Will Top Arena’s Despite REMS
The FDA has approved Vivus’ Qsymia, formerly Qnexa, as the second new weight-loss drug in as many months, and analysts predict it may take the lion’s share of the anti-obesity market. But unlike Arena Pharmaceutical’s Belviq (lorcaserin HCl), approved last month, Qsymia (phentermine/topiramate) has a risk evaluation and mitigation strategy (REMS) that focuses on the increased risk of birth defects associated with first-trimester use, the need for pregnancy prevention and the need to discontinue use of the drug if pregnancy occurs.
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