Endo’sPar Pharmaceutical Inc. has won US Food and Drug Administration approval for the first generic version of Pfizer’s Chantix (varenicline) tablets, “well ahead of the review goal date,” the agency noted, “which could help mitigate the current shortage of the drug.”
FDA Looks To Solve Chantix Shortage With Par ANDA Approval
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Endo’s Par looks set to provide much needed supply in the US market for varenicline tablets, after originator Pfizer ran into supply and distribution problems due to the presence of a nitrosamine for its Chantix original.
