LONDON (AP) – AstraZeneca PLC says the U.S. Food and Drug Administration will take more time to review the British company’s application for vandetanib, a drug it is developing as a treatment for a rare type of thyroid cancer.
AstraZeneca said Friday that it has submitted a risk evaluation and mitigation strategy at the FDA’s request.
The FDA has extended its review completion date from Jan. 7 to April 7.
AstraZeneca is seeking approval for vandetanib as a treatment for inoperable medullary thyroid cancer that has either metastasized or advanced locally.
AstraZeneca originally applied for approval of the drug in June 2009 under the name Zactima. But it withdrew those applications in October 2009, saying U.S. and European regulatory agencies were unlikely to approve the drug.
Date: January 7, 2010
Source: Associated Press
Filed Under: Drug Discovery