MFDS lifts nizatidine sales ban, Alvogen cancels license

MFDS clears sales ban on products completed recall

Affected companies to ship products only after testing NDMA by each serialization

5 out of 13 suspended products still working on recall

Alvogen Korea has reportedly cancelled the item license on its nizatidine drug, although its sales ban for containing the unacceptable level of cancerous NDMA was listed.

 

The case proves lifting the sales ban and a company’s will to sell the product are two different matters.

 

On June 25, Korea’s Ministry of Health and Welfare (MOHW) has announced the reimbursement suspension on Alvogen Korea’s seven nizatidine items including Zanitidine tablet 75 mg was listed as notified by Ministry of Food and Drug Safety (MFDS).

 

But apparently Alvogen Korea has cancelled the sales license on Zanitidine tablet 75 mg as of June 24.

 

Ironically, the company returned the license of the product cleared from sales ban.

 

The license cancellation would take Zanitidine tablet 75 mg off the shelf, unless the company reapplies for the license.

 

Technically, such odd situation occurred as the sales ban was lifted not because the responsible company followed through with the process to resume selling the product.

 

Once the pharmaceutical company completes the suspended nizatidine product recall, MFDS allows the product sales to be resumed.

 

But the company has to test NDMA level by each production serialization, and only the acceptable products can be released.

 

The test results are not for MFDS submission, but to be archived by the company.

 

The recall on Alvogen’s Zanitidine tablet 75 mg has been done, but the company’s action could be interpreted that it has no intention to immediately resume sales.

 

Currently, the sales ban on eight out of 13 nizatidine products has been cleared and they can be prescribed normally.

 

MFDS lifted the ban on the products as the responsible companies have fully recalled the products.

 

The other five items cannot be prescribed as the process is unfinished.