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Indiplon Driving Study Could Add Marketing Momentum; Action Date Delayed

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer and Neurocrine Biosciences expect labeling for their insomnia drug indiplon could include language that the product does not appear to cause next-day sedation or driving impairment.

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Pfizer/Neurocrine indiplon resubmission

Merck's human papillomavirus vaccine Gardasil shows a higher efficacy rate in adolescents (male and female) aged 10 to 15 than in young women aged 16 to 23, according to a Phase III study presented May 19 at the European Society of Pediatric Infectious Diseases. In the 1,529-patient trial, seroconversion rates in the combined adolescent cohort (506 female, 510 male) were 100% for HPV types 16, 6 and 11, and 99.9% for HPV 18. Results were identical in the 513 16-23-year old women, except for serotype 18, for which Gardasil produced a 99.1% conversion rate. The study comes on the heels of a Phase II trial published in the April issue of Lancet Oncology, in which the quadrivalent vaccine was shown to significantly reduce the combined incidence of persistent HPV 16, 18, 6 or 11 compared to placebo. Merck plans to file a Gardasil BLA in the second half of 2005 (1Pharmaceutical Approvals Monthly May 2005, In Brief)...

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

September 2010 Approvals






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