FDA requests removal of all Ranitidines from the market

Last hope for stability proof

The FDA's decision made Korea's preemptive measures reasonable

Ranitidine products collected for recovery

As the Food and Drug Administration (FDA) decides to withdraw all products containing Ranitidine on the 1st, domestic pharmaceutical companies seeking to resume sales are embarrassed Until recently, some Ranitidine products were on sale in the US market, so it was expected that if the stability data were submitted in Korea, it would be possible to resume sales sufficiently.

 

However, the FDA also hopes that if a pharmaceutical company demonstrates safety and stability through scientific data, it may consider resuming sales.

 

The FDA said on the 1st that it had requested the manufacturer to collect all of the Ranitidine drugs to withdraw immediately from the market.

 

The FDA has requested voluntary recalls for some lot numbers of Ranitidine.

 

However, in this announcement, it was explained that Ranitidine have increased in carcinogenic substance NDMA (N-nitrosodimethylamine) over time in a general storage environment and recovered in full quantity.

 

This action is similar to the action taken by the MFDS on September 26 of last year.

 

In response to this, an official from the Food and Drug Administration said that there were criticisms that the domestic measures were excessive but the FDA's decision made Korea's preemptive measures reasonable.

 

However, the situation was uncomfortable for companies that were aiming to resume sales of ranitidine formulations.

 

An official from the related company said that the company had been conducting sales resumption through verification that NDMA was not generated even over time, but the FDA's decision will make the MFDS to resume sales more conservatively.

 

Companies that had high sales of Ranitidine formulations expected it would be possible to resume sales.

 

In particular, the U.S.

 

FDA said that the risk of NDMA is not high in Ranitidine formulations, some companies voluntarily recovered it and sold it in the market.

 

Therefore, the prospect was high that the MFDS would allow sales to resume.

 

However, it was analyzed that a more thorough verification was inevitable for the resumption of sales of Ranitidine due to FDA's decision to withdraw.

 

The MFDS has adhered to the principle that, in order to resume sales, manufacturers must prove that NDMA is not produced in the product for a long time.

 

However, the stability period was not specified, and the industry complained of inconvenience.

 

However, some officials from the MFDS have often said that the cause of NDMA production of Ranitidine preparations is a structural problem, and the longer the storage period, the greater the risk, making it difficult to make a decision to resume sales.

 

Nevertheless, manufacturers watched the overseas situation and thought it would be a resumption of sales.

 

Earlier, an official from the company said that the EMA is expected to produce results as soon as possible after the US FDA.

 

and added that if the action of an advanced institution is to expel Ranitidine, it is inevitable to review the sales resumption strategy.

 

On the other hand, there is a response that it is too early to discuss the complete withdrawal because the FDA said that, like the Ministry of Food and Drug Safety, it will allow sales to resume if related companies prove it with scientific data.

 

The FDA responds to this action if the company shows that, through scientific data, their Ranitidine products are stable and that NDMA levels do not increase to an unsafe level over time, the FDA will release the Ranitidine products to the US market.

 

The FDA also added that it did not withdraw its application for commercial approval of Ranitidine.

 

The MFDS also said that there has been no change in relation to the resumption of sales.

 

The MFDS said that no pharmaceutical companies have submitted data regarding the resumption of sales to date.