Aloxi GMP Problems May Trigger Import Controls
This article was originally published in The Pink Sheet Daily
France's Pierre Fabre Medicament Production could find the antiemetic it manufactures for Eisai is barred from the U.S. until it takes corrective action on manufacturing problems.
You may also be interested in...
TOKYO - Quadrupling profits in the business year from the preceding year and forecasting a solid 17.5 percent rise in the current year, Eisai Co., the fourth-largest Japanese pharma and the only one reporting profit among the four, said it will further reinforce its oncology drug development and sales while accelerating global distribution of Alzheimer's treatment Aricept
Antiemetic gained through MGI acquisition competes with oral therapies Zofran from GSK and Roche’s Kytril .
U.S. FDA has approved a new indication for Japan-based Eisai's Aloxi (palonosetron hydrochloride) for post-operative nausea and vomiting in the first 24 hours after surgery. The drug maker announced approval of the expanded indication March 3 for the drug it obtained through the acquisition of MGI Pharma earlier this year (PharmAsia News, Jan. 24, 2008).