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  • MFDS in a month-long silence regarding Champix issue
  • by | translator Alice Kang | Jul 7, 2021 05:54am
Health authorities have not made any official statement regarding nitrosamine impurities
Pfizer did not notify distributors of the potential impurity concerns¡¦mentioned possibility of resuming supply in July
Unlike U.S. or Canada, no prescription or administration guidelines for Champix exists in Korea¡¦new prescriptions were made even after the impurity issue surfaced
Confusion in the field continues as the impurity issue of the smoking cessation treatment ¡®Champix(varenicline)¡¯ remains unresolved. Contrary to the U.S. and Canada, where the authorities preemptively provided guidelines to patients and HCPs while notifying them of the product recall and the possibility of impurities, the Korean health authorities have kept their silence for over a month.

The Ministry of Food and Drug Safety had ordered Champix manufacturer Pfizer and other domestic manufacturers to investigate the impurities earlier last month. However, this fact was not publicly announced by the authorities and was disclosed through Dailypharm¡¯s report on the 14th of last month.

Pfizer had first stopped t
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