Nplate
Generic name: romiplostim
Treatment for: Immune Thrombocytopenia, Hematopoietic Syndrome of Acute Radiation Syndrome
Amgen's FDA Nplate Approval Statement Retracted
Amgen's FDA Nplate Approval Statement Retracted
THOUSAND OAKS, Calif., July 14, 2008 — Biotechnology company Amgen Inc. said Business Wire erroneously released a statement from the company Monday, saying the Food and Drug Administration approved its Nplate treatment for a rare type of blood-platelet deficiency condition.
In a separate statement, Business Wire said it prematurely issued the press release.
The drug is in fact still under review by the FDA and the company expects a decision by July 23.
The company said its announcement about the FDA approval, which was released Monday morning, was incorrectly distributed.
Nplate is designed to treat the autoimmune disorder chronic immune thrombocytopenic purpura, in which the number of platelets in a person's blood declines, leading to serious bleeding.
© Copyright 2008 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Posted: July 2008
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- FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP - August 22, 2008
- FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP - July 14, 2008
- Amgen Statement on Successful Outcome of Romiplostim Panel Meeting - March 13, 2008
- Amgen to Discuss Romiplostim Application at FDA ODAC Meeting - March 12, 2008
Nplate (romiplostim) FDA Approval History
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