|Status||‒ CRL on February 24th, 2023.
‒ Handa will supplement deficiencies and submit to FDA ASAP.
|Product Advantages||ANDA product|
|Potential Market||HND-032 is a generic drug product with Pfizer Inc.’s brand drug Chantix/Champix as the reference product. Chantix/Champix was tested “Nitrosamine” exceeding the standard in 2021, and Pfizer immediately recalled it in the world. According to the data in the annual report of Pfizer, the total sales of Chantix/Champix in 2021, 2020 and 2019 were US$398 million, US$919 million and US$1.107 billion, respectively.|