Foltx® Color Change Announcement
- How can the change in appearance be described?
The color of Foltx® will soon change to a tint that can be described as changing from a "Flesh" color to a "Beige" color.
- What caused the change in appearance?
The color change is due to a change in Foltx® tablet's coating material. The old coating material was Opadry II Flesh Y-22-13577. The new coating material will be Opadry II Beige 40L17427.
- Why is this change being made?
Pamlab no longer has Opadry II Flesh Y-22-1357 available for use with Foltx®. Opadry II Beige 40L17427 was selected as the closest FDA approved color alternative.
- When will this change begin to be seen in the marketplace?
It is anticipated that the change will be seen in the distribution system in the mid-late September, 2007 time-frame.
- Should Foltx® tablets colored with Opadry II Flesh Y-22-13577 be returned?
No. This is planned cosmetic change and in no way affects the quality or purity of the current Foltx®. Your current stock of Foltx® should continue to be distributed in the market place and dispensed to patients.