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NeutrogesX announces on schedule response to EMEA's day 120 questions |
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News -
Nanomedicine and Drug Delivery News Archive
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Wednesday, 24 September 2008 |
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NeurogesX, Inc. announced that it has responded to the European Medicines Agency's (EMEA) Day 120 questions on schedule.
The Day 120 questions are part of the process for the Marketing Authorization Application (MAA) for NGX-4010 in peripheral neuropathic pain, accepted by the European Medicines Agency in September 2007. The EMEA's Day 120 questions form a part of its ongoing review process. NeurogesX, after their timely submission of the responses has plans to submit a new drug application by the end of 2008.
The biopharmaceutical company's focus is on developing and commercializing new pain management therapies, specifically on chronic peripheral neuropathic pain. Proposed products include NGX-4010, a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions and a topical liquid formulation containing capsaicin, NGX-1998, which was previously studied in two Phase 1 studies in healthy volunteers conducted under an exploratory investigational new drug application.
Source: NeurogesX, Inc. |