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September 2009 Approvals

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

September Approvals

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Business News In Brief

Novartis runs counter to sales call trends for first half of 2010: With a strong emphasis on detailing newly launched hypertension drug Valturna (aliskiren/valsartan), Novartis saw its volume of sales calls to doctors, nurses and physician assistants increase 7 percent during the first half of 2010, in contrast to industry trends. In a newly issued report, health care market analytics firm SDI announced overall sales calls by pharma companies to clinicians decreased 1 percent during the first six months of the year, compared to the second half of 2009. Based on SDI's findings, Merck sales calls declined 16 percent and GlaxoSmithKline's 7 percent. The industry's biggest company, Pfizer, posted a 2 percent decrease in sales calls during the half-year. At Novartis, a full 19 percent of sales calls were used to discuss Valturna, a combination drug approved by FDA last September that comprises the active ingredients in Diovan and Tekturna (1Pharmaceutical Approvals Monthly, October 2009). With pharmaceutical sales forces being reduced in recent years, the drop in sales calls may be slowing, SDI Associate Director of Syndicated Analytics Jason Fox said, but in-person calls remain the most popular method of informing clinicians of new drugs, second only to product sampling

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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