The Ministry of Food and Drug Safety has suspended the sales of GSK's Tivicay 50mg Tab., a human immunodeficiency virus-1 (HIV-1) treatment, for 15 days for failing to submit documents in applying for drug reexamination.

According to industry sources, the ministry issued the 15-day sales suspension order from July 23 to Aug. 6.

The administrative discipline comes after the Central Pharmaceutical Affairs Council adjusted the number of post-marketing surveillance (PMS) cases of Tivicay from 3,000 to 90, considering the clinical necessity and the disease’s characteristics in September of last year.

GSK followed the PMS by conducting about 20 percent more than the 90 cases required, but the ministry suspended sales of the drug as the company had failed to submit any official documentation.

The new drugs reexamination rules stipulate that a company must submit a revised investigation plan in advance if there is a need to change matters, such as the patient group, the total number of subjects, the period of investigation, and the investigation method related to the post-marketing investigation.

GSK said it submitted a statement of reason, but the ministry did not recognize it as an official document.

"We submitted a statement of reason regarding as to why we increased post-marketing investigation cases and supporting data, but the ministry did not recognize our documents as official," a GSK official said to Korea Biomedical Review. "It is true the ministry notified us of the sales suspension due failing to submit changes concerning the reexamination, but the move has nothing to In response to the ministry's prior notice on Tivicay's sales suspension, the company also submitted an explanatory opinion twice and reduced the suspension period from one month to 15 days, she added.

The official stressed that GSK would do its best not to let this happen again in the administrative reporting process.

Tivicay is indicated to treat HIV-1 infection in adults and adolescents 12 years of age and older in combination with other antiretroviral agents. According to an IQVIA, a market research firm, the drug had posted sales of 990 million won ($857,880) in the first quarter of this year.