Medytox won a lawsuit against the Ministry of Food and Drug Safety (MFDS) in a three-year battle over the product approval cancellation of its Meditoxin lineup, its botulinum toxin (BTX) product, for alleged use of unauthorized raw materials.

According to Medytox, the Daejeon District Court ruled in favor of Medytox in the lawsuit filed against the Daejeon MFDS, which sought to cancel Meditoxin's product licenses.

The court ordered the cancellation of the MFDS's decision to revoke the product approvals and the suspension of manufacturing and sales orders for Meditoxin in 50, 100, and 150 unit doses.

"The court's decision, through a clear legal interpretation of the Pharmaceutical Affairs Act, judged the MFDS's suspension of manufacturing and sales orders and cancellation of product approvals for Medytox as unlawful," a Medytox official told Korea Biomedical Review. "Based on this ruling, we will do our best to further develop and grow Medytox."

Following the decision, Medytox's stock price closed slightly up at 221,500 won ($168), an 1.84 percent increase from the previous trading day.

This legal dispute between Medytox and the MFDS first started in June 2020, when MFDS deemed that Medytox had changed the raw materials without reporting and without approval.

The MFDS subsequently canceled the product approvals for Meditoxin in 50, 100, and 150 unit doses and issued a manufacturing and sales suspension.

Medytox immediately objected, arguing that only the manufacturing process had changed and not the raw material.

As a result, the company stressed that they should face only a one-month suspension of manufacturing and sales for changing the manufacturing method without making an official report.

Medytox promptly filed a lawsuit and a suspension of execution against the MFDS's cancellation of product approvals.

In August of the same year, the court accepted the request to suspend the execution of the product approval cancellation and recall and disposal orders for Meditoxin.

Industry officials expect that the ruling will alleviate uncertainty related to the cancellation of product approvals for Meditoxin, which accounts for the majority of Medytox's sales, nearly 70 percent in 2019.

The ruling is the second big win for Medytox against the MFDS.

The company had previously won another legal battle against the MFDS over indirect exports in July.

The case started when the MFDS deemed Medytox's practice of "indirect export" of BTX to be illegal domestic sales as it did not receive a separate national lot release approval process in 2020.

Biopharmaceuticals currently sold domestically must go through a separate national lot release approval process to check for adulteration and foreign substances.

Still, Medytox engaged in indirect export by selling its BTX products to local distributors without getting a lot release approval.

However, the Daejeon District Court ruled in favor of Medytox and revoked MFDS' product license revocation decision for Meditoxin and Coretox and also the order to stop sales, recall, and destroy such products.