Millennium Plans to Submit a New Drug Application for Velcade (Bortezomib) for Injection
- Topics:
- Pharmeceuticals
- Tags:
- FDA,
- Federal Government,
- Government,
- Millennium Pharmaceuticals Inc.,
- New Drug Application,
- VELCADE
- Source:
- Millennium Pharmaceuticals
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Overview: In this article Millennium Pharmaceuticals, Inc. informs that the Company intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) to market VELCADE as a treatment for relapsed and refractory multiple myeloma by early 2003. Earlier this year, VELCADE was granted fast-track status by the FDA as having the potential to treat a serious, life-threatening condition and address an unmet medical need. The NDA is planned to be submitted under the provisions of Subpart H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses.
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Millennium Submits New Drug Application for VELCADE (Bortezomib) for Injection |
