Endo International plc announced that one of its operating companies, Par Pharmaceutical, Inc. (Par), has begun shipping the generic version of Pfizer's Chantix® (varenicline), 0.5 mg and 1 mg tablets, following final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application.
Par's varenicline is the first and currently the only available FDA-approved generic version of Chantix® in the U.S.
"This important approval brings the first Chantix® generic to the U.S. market," said Jon Holden, Senior Vice President and General Manager, Generics at Endo. "As a reliable, quality supplier, Par is proud to help people during this critical time while also expanding our product portfolio."
According to IQVIA™, Chantix® tablet sales were approximately $1 billion for the 12 months ended June 30, 2021.
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