The Wall Street Journal (5/8, Stynes, Subscription Publication, 2.29M) reports Arena Pharmaceuticals Inc. announced Tuesday that the US Drug Enforcement Administration filed a final rule to designate its weight-loss therapy, Belviq (lorcaserin HCI), under Schedule IV of the Controlled Substances Act. The US Food and Drug Administration approved Belviq last summer, making it the first anti-obesity medication approved by the agency in more than 10 years.
According to Bloomberg News (5/8, Edney), the DEA reviewed Belviq because the FDA "said the active ingredient, lorcaserin, can produce a high or hallucinogen effect at doses greater than those used to produce weight loss." The Schedule IV level is the second-least restrictive classification under the rule (pdf), which the DEA made public yesterday.
The U-T San Diego (5/8, Fikes, 242K) adds that the DEA designation cleared the way for Arena to begin selling Belviq on the US market. Sales "can begin 30 days from publication of the DEA approval," which Arena expects will be printed in today's Federal Register. Its marketing partner, Tokyo-based Eisai Pharmaceuticals, will manage the sales and distribution of Belviq in the US, Arena said in the announcement.
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