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FDA ban set to cost Aurobindo $26 m Aurobindo Pharma


FDA ban set to cost Aurobindo $26 m
Aurobindo Pharma has received an alert warning from the US drug regulator for not meeting the compliance at one of its units in Hyderabad. The US Food and Drug Administration has raised concerns on APL's Unit VI and banned shipment from this unit, which manufactures cephalosporins.

FDA extends phytosterol compliance period
According to the proposed rule in the Federal Register , dated December 8, 2010 (Vol. 75, Number 235), the change would provide opportunities for a CHD phytosterol claim for foods including bread and cereal, orange juice, and low-fat dairy foods, as well as allowing non-esterfied phytosterols to make the claim.

FDA clears Agendia's breast cancer recurrence assay
Agendia, a world leader in molecular cancer diagnostics, today announced that the company has received its fifth U.S. Food and Drug Administration clearance for MammaPrint, its widely used breast cancer recurrence assay.
 

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