MFDS imposes fine on imported Nesina Met and Xeomin

List of administrative measures as of Aug. 7 disclosed, fined up to KRW 30.15 million

Charges on incomplete data submission for PMS and serialization omission

Takeda Pharmaceuticals Korea’s antidiabetic drug Nesina Met and other imported drugs have received administrative measure from Korea’s Ministry of Food and Drug Safety (MFDS).

 

Specifically for Nesina Met, the importer would be responsible for the health authority’s 30.15 million won fine that substituted a three-month sales ban.

 

On Aug.

 

13, MFDS disclosed a list of administrative measures imposed as of Aug.

 

7 with the said details.

 

Besides Nesina Met, other imported botulinum toxin products were also found on the list.

 

Takeda Pharmaceuticals Korea’s Nesina Met was fined with 30.15 million won, instead of a three-month ban, as the company neglected submission of required data for the post-marketing survey (PMS) reevaluation.

 

The fine is due on Sept.

 

7.

 

An alogliptin benzoate plus metformin hydrochloride combination antidiabetic drug, Nesina Met was approved for the Korean market in February 2015.

 

Currently the drug is imported to Korea by Takeda Pharmaceuticals Korea.

 

The PMS reevaluation on Nesina Me was completed as of May last year.

 

For a new drug, the company had to submit usability investigation data like adverse reaction report to MFDS during the reevaluation period.

 

Omitting a part of required data submission once gets a three-month sales ban, and twice gets a six-month sales ban.

 

However, the penalty can be replaced with a fine.

 

A dipeptidyl peptidase-4 inhibitor, Nesina Met has made 3.4 billion won in outpatient prescription from the first half of the year, according to UBIST.

 

Administrative measures on some imported pharmaceuticals as of Aug.

 

7 (Source: MFDS)

Two imported botulinum toxin products competing against Korean botulinum toxin products have also received administrative measure due to an omission of serial number.

 

Merz Asia Pacific omitted serialization information when reporting supply history and shipping of ‘Xeomin injection’ and ‘Xeomin injection 50 unit’ from July through December 2019.

 

As a result, the health authority imposed a fine of 14.85 million won due Sept.

 

7, substituting a month-long sales ban.

 

Ipsen Korea has also gotten a sales ban on a botulinum toxin Dysport injection for to the same charges.

 

From July through December 2019, the company also omitted to report Dysport serialization along with its supply record.

 

The product sales would be banned for ten days from Aug.

 

21 to 30.

 

Xeomin and Dysport have been imported to Korea for 4.6 billion won and 900 million won, respectively, in 2018.

 

The two products together take up a small pie of 2.7 percent in the Korean botulinum toxin market.

 

The serialization system has been enforced since January 2019.

 

The government has mandated reporting of product serial number when a company ships out the products to improve transparency in distribution and user safety.

 

Same administrative measures were given on Ipsen Korea with the same charges.

 

The sales on Diphereline PR injection and Diphereline SR injection would be banned for ten days from Aug.

 

21 to 30.