The Ministry of Food and Drug Safety (MFDS) is taking administrative action against Korean pharmaceutical companies that advertised the generic drugs of Forxiga (dapagliflozin) as effective for chronic kidney failure and other effects than approved indications.

According to ministry sources Wednesday, the ministry has investigated cases of pharmaceutical companies advertising outside of the approved indications and is taking action against violators.

Forxiga is AstraZeneca's SGLT-2 inhibitor, an original drug based on dapagliflozin. SGLT-2 inhibitors, along with DPP-4 inhibitors, have recently gained prominence in the treatment of diabetes. Forxiga's product group generated annual sales of 100 billion won ($79 million) in Korea.

The off-label advertising of the generics of Forxiga has come under scrutiny since April. Many domestic pharmaceutical firms have launched generics to coincide with the expiration of Forxiga's patent, and some have promoted their product’s efficacy for chronic heart failure or chronic kidney disease, which are not licensed indications.

For example, a company known only as H, touted its Forxiga generic’s effectiveness in treating chronic heart failure and chronic kidney disease with the phrase “Heart, Kidney, Diabetes, and Added Benefits” as it launched the product.

AstraZeneca has secured three indications for Forxiga through clinical studies -- type 2 diabetes, chronic heart failure, and chronic kidney disease. However, generics launched in Korea have only been licensed for type 2 diabetes, as part of Forxiga's patent remains valid.

According to Article 68 of the Pharmaceutical Affairs Act, no one can advertise an unapproved drug's efficacy or performance without winning or modified approval.

"We are taking measures, including forced disposition, and the administrative disposition information will be disclosed through a website on medical product safety,” a ministry official said. "First-time offenders will be suspended from advertising for three months."