Determination That CHANTIX (Varenicline Tartrate) Tablets, 0.5 Milligram and 1 Milligram, Has Not Been Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) has determined that CHANTIX (varenicline tartrate) tablets, 0.5 milligram (mg) and 1 mg, has not been withdrawn from sale for reasons of safety or effectiveness to the extent that the drug can be manufactured or formulated in a manner that satisfies any applicable acceptable intake limit for nitrosamine impurities. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
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