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MFDS in a month-long silence regarding Champix issue

By | translator Alice Kang

21.07.06 17:20:29

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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.

Pf

(same@dailypharm.com)
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