Nplate
Generic name: romiplostim
Treatment for: Immune Thrombocytopenia
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 This material may not be published, broadcast, rewritten, or redistributed.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
Related articles
- Nplate (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia - October 18, 2019
- FDA Approves Nplate (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia - December 14, 2018
- 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
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
