FDA Supports Limited Distribution Of Pfizer's Antismoking Pill, Chantix

Earlier this month, the FDA alerted that Pfizer Inc PFE had voluntarily recalled its smoking cessation drug, Chantix, after finding elevated levels of cancer-causing nitrosamines.
In guidance released Friday, the FDA set an interim allowable limit for that compound in Chantix at 185 ng per milliliter to help ensure adequate drug supply in the U.S.
Now, the FDA is permitting certain manufacturers to temporarily distribute the drug with an acceptable intake limit of 37 ng per day but below the interim permissible intake limit of 185 ng per day until the impurity can be eliminated or reduced to acceptable levels.
Pfizer previously halted the distribution of Chantix and pulled four lots of the drug after finding high levels of the nitrosamine N-nitroso-varenicline in routine testing.
In addition to the voluntary recall, Pfizer is holding the release of varenicline to the U.S. market until it can confirm N-nitroso-varenicline levels below what the company considers acceptable.
Price Action: PFE shares are down 0.99% at $39.95 during the premarket session on the last check Monday.