Telavancin Application Withdrawn In Europe, To Be Reworked With HAP Indication
This article was originally published in The Pink Sheet Daily
FDA advisory panel will review NDA that includes more safety data for the antibiotic than the European MAA did.
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FDA will resume the review of Theravance’s antibiotic telavancin at a three-day advisory committee meeting in November after completing an audit of the company’s clinical trial data.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.