The Ministry of Meals and Drug Security has suspended importing three Viatris Korea’s eye drop merchandise for one by way of Aug. 14.
The suspension of import enterprise was because of the firm’s failure to report the adjustments within the manufacturing consumer after the merger of the Upjohn division of Pfizer and Mylan, the ministry mentioned.
The suspension will proceed by way of Aug 14.
The three merchandise — Xalatan Eye Drops 50μg/mL, Xalatan Eye Drops 50μg/mL(single use), and Xalacom Eye Drop – are prescribed to decrease intraocular stress in sufferers with glaucoma and ocular hypertension. In keeping with IQVIQ, a drug market analysis agency, the 2 Xalatan merchandise posted gross sales of 13.4 billion received ($1.01 million) and Xalacom, 1.1 billion received final yr.
Viatris Korea admitted the corporate delayed reporting the modified data on the drug after its merger in November 2020.
“Viatris Korea’s Xalatan and Xalacom not too long ago acquired an administrative disposition from the Ministry of Meals and Drug Security to droop import for one month resulting from resulting from a delay in finishing an administrative software,” mentioned Park Su-hee, Viatris Korea’s company communications supervisor. “Viatris Korea will cooperate with the Ministry of Meals and Drug Security and different related authorities.”
Nonetheless, Park emphasised that regardless of the disposition, there will likely be no disruption to the provision and distribution of merchandise.
“There are not any manufacturing or high quality considerations for the merchandise, and we’re assured of supplying high quality merchandise to Korean hospitals and clinics,” Park mentioned. “Viatris Korea will proceed to work to make sure the provision of high quality merchandise for sufferers and prospects we serve.”
Park emphasised that there isn’t any influence on the provision and distribution of merchandise to wholesalers and hospitals, including that Viatris Korea markets no different merchandise with delayed notification of adjustments.
“Right now, this concern solely pertains to Xala-brand,” she mentioned.
