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2008 NME approvals reach ten, with seven in the first half and three so far in the second

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA approved seven new molecular entities in the first half of 2008, equal to the first-half total for 2007. Pharmaceutical Approvals Monthly erred in reporting six first-half approvals; Sirion's Durezol (difluprednate), approved June 23, was absent (1Pharmaceutical Approvals Monthly July 2008, p. 3). Durezol is indicated for treatment of inflammation and pain associated with ocular surgery. FDA needs to clear ten NMEs in the second half of 2008 if it is to exceed 2007's record low total of 16 NMEs. The NME approval tally stands at ten as of the last week of August. Bayer's imaging agent Eovist (gadoxetate) was approved July 3, The Medicines Company's I.V. antihypertensive Cleviprex (clevidipine) cleared the agency on Aug. 1, and Prestwick's orphan Xenazine (tetraberazine) was approved Aug. 15 for Huntington's chorea


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