Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for MYLOTARG
Health and Human Services Department, Food and Drug Administration
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Key Details
- Posted Date
- Response Deadline
- NAICS Code
- 325412
- Source
- Federal Register
- Contract Type
- regulation
Description
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for MYLOTARG (gemtuzumab ozogamicin) for Injection, held by Wyeth Pharmaceuticals, Inc. (Wyeth), 500 Arcola Rd., Collegeville, PA 19426. Wyeth, now a part of Pfizer, Inc., has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
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