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The article reports that the U.S. Food and Drug Administration (FDA) has delayed the approval of Pozen Inc. and GlaxoSmithKline's Trexima for the second time in the U.S. Reportedly, the FDA delayed the first approval of this drug in January 2007 where additional safety data from clinical trials were requested. In the second delay, the FDA requested Pozen to address the agency's concern about an in vitro study where genotoxicity was seen for the combination of naproxen sodium and sumatriptan.

The article focuses on the tentative approval received by Teva Pharmaceutical Industries Ltd. for sumatriptan succinate anti-migraine drug from the U.S. Food and Drug Administration. The firm has become the latest addition to companies that aim to challenge the Imitrex drug of GlaxoSmithKline. Sumatriptan tablets represent a valuable addition to the company's generics portfolio. The availability of generic sumatriptan in European countries has resulted in a decline in sales of Imitrex.