The long wait to get obesity drug Belviq (lorcaserin) to the US market, where it was approved by the Food and Drug Administration nearly a year ago, is coming to a close, but not just yet. While finally getting a feedback from the US Drug Enforcement Administration, the effective date of the scheduling designation will be 30 days after today’s (May 8) expected publication in the Federal Register.
The DEA, which was charged with determining the drug’s abuse potential, issued a ruling on Tuesday establishing Arena Pharmaceuticals (Nasdaq: ARNA) and Japanese partner Eisai's (TYO: 4523) obesity therapy Belviq as a Schedule IV drug (the second-least restrictive designation) under the Controlled Substances Act. The companies will now be able to launch the product after the effective date. Arena rose 8.1% to $8.13 in midday New York trading.
Last year, the FDA also approved Vivus' obesity drug Qsymia (phentermine/topiramate), which was launched in September, although so far with disappointing sales. Qsymia is also listed as Schedule IV by the DEA.
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