Hyundai Pharm obtains approval for new contraceptive

Hyundai Pharm said it has received approval from the Ministry of Food and Drug Safety (MFDS) for Slinda 4mg (ingredient: drospirenone), its new oral contraceptive.

In 2022, Hyundai Pharm entered into an exclusive licensing agreement with Japan's ASKA Pharmaceutical for the Korean commercialization rights of Slinda.

The drug, which has already been approved in the U.S. and Europe, was developed by Exeltis, the women's health division of Spanish multinational Insud Pharma. ASKA Pharmaceutical holds commercialization rights in the Korean and Japanese markets.

Slinda is a progestin-only contraceptive pill containing drospirenone and does not include estrogen. This reduces the risk of estrogen-related side effects, making it suitable for women over the age of 35 who smoke and may have difficulty using traditional contraceptives.

According to World Health Organization (WHO) guidelines, progestin-only pills like Slinda are recommended for women with multiple risk factors for cardiovascular diseases, such as age, smoking, diabetes, and hypertension. It is also recommended for women who have experienced deep vein thrombosis or pulmonary embolism.

With the approval of Slinda, Hyundai Pharm has further strengthened its portfolio in the Korean contraceptive market. The company already offers a range of contraceptive options, including -emergency contraceptives -- EllaOne and NorLevo One --, and the second, third, and fourth-generation oral contraceptives -- Rania, Bonita, and Yaroz.

"We expect Slinda to provide a new prescription option for women who have had difficulties using contraceptives due to side effects," a Hyundai Pharm official said. "We encourage women to consult with healthcare professionals to select the most appropriate product considering their health status and underlying conditions."