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Telavancin's "Complete Response" Letter Calls For Pregnancy-Focused REMS

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

After a three-day, three-drug advisory committee in November, the last sponsor standing - or at least the last to get a "complete response" letter from FDA - may be in the best position to move forward with its complicated skin and skin structure infections antibiotic

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Antibiotic updates

The first of the novel antibiotics under review at FDA for treatment of complicated skin and skin structure infections has met with an approval, with the Sept. 11 clearance of Theravance/Astellas' Vibativ (telavancin). The approval comes a year after an FDA advisory committee reviewed three novel antibiotics - telavancin, Targanta's oritavancin and Arpida's iclaprim - determining that tighter non-inferiority margins were needed for cSSSI trials. FDA had issued "complete response" letters for all three drugs; telavancin was the only one that didn't need to do another trial (1Pharmaceutical Approvals Monthly March 2009). The Medicines Company, which acquired Targanta, withdrew the European marketing application for oritavancin Aug. 20, several months after pulling the NDA from FDA. But the regulatory climate for antibiotic drug development that targets severe infections or multi-resistant organisms could be clearing up, according to a former office director speaking at the recent ICAAC conference (2"The Pink Sheet," Sept. 21, 2009). Progress is also occurring on J&J/Basilea's ceftobiprole; a recent warning letter may actually signal that FDA has processed the data integrity issues that have delayed that approval (3"The Pink Sheet" DAILY, Aug. 19, 2009)

FDA Updating Antibiotic Guidances, But Is It Too Late For Some Sponsors?

It was supposed to be a year with a wealth of novel antibiotics, but regulatory concerns turned 2008 from a year of banner antibiotic approvals into a sizeable crop of action letters. Now the delays are taking a serious toll, causing some sponsors to drastically restructure in the face of uncertain and evolving regulatory standards

Forest Savella’s Launch For Fibromyalgia: Many Sales Forces, Single Claim

Forest's promotional messaging for the launch of its fibromyalgia drug Savella (milnacipran) has a somewhat unusual emphasis - the product's limited utility

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