Hyundai Pharm files for marketing approval of Natesto in South Korea


Hyundai Pharm has filed for the marketing approval of Natesto, a nasal gel formulation of testosterone, with South Korea’s Ministry of Food and Drug Safety (MFDS).

Developed by Canadian company Acerus Pharmaceuticals, Natesto is indicated as a replacement therapy for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).

Acerus Pharmaceuticals president and CEO Tom Rossi said: “Acerus is very pleased by the speed with which Hyundai Pharm has been able to prepare the dossier and file Natesto with MFDS.

“It’s a testament to their commitment to the future success of Natesto.”

On receipt of the marketing approval, Natesto will be the first and only testosterone nasal gel indicated for the treatment of low testosterone in South Korea.

"We look forward to working with the MFDS regulatory authorities to bring Natesto to the South Korean market."

Hyundai Pharm CEO and president Young Hak Kim said: “We look forward to working with the MFDS regulatory authorities to bring Natesto to the South Korean market.

“This product is an important advance for patients suffering from low testosterone in South Korea. Its unique nasal administration, safety and efficacy represent a clear opportunity to improve patient’s quality of life.”

In December last year, Hyundai acquired an exclusive licence from Acerus to market the product in South Korea.

Approved by the US Food and Drug Administration (FDA) and Health Canada, Natesto is available in a ‘no-touch’ dispenser with a metered dose pump.

Hyundai is engaged in various therapeutic categories such as CV, respiratory system, women’s and men’s health, CNS, and oncology with specialised products.