#Japan #Daiichi Sankyo #Tokyo #Norlevo #Aska Pharmaceutical

Aska Pharmaceutical's Emergency Contraceptive Norlevo Approved as OTC

In a significant move towards enhancing women's health services, Aska Pharmaceutical Co. has announced on October 20, 2023, that it has obtained manufacturing and sales approval for its emergency contraceptive, Norlevo (generic name: Levonorgestrel), under the switch OTC classification. This important breakthrough allows Norlevo, formerly available only through prescription, to be sold directly to consumers, thereby facilitating easier access to emergency contraception for women in Japan. The approval is expected to address growing demand for contraceptive options and empower women to manage their reproductive health more effectively.

Aska Pharmaceutical, headquartered in Minato-ku, Tokyo and led by President Soichi Yamaguchi, has been at the forefront of developing innovative pharmaceuticals that cater to critical health needs. The introduction of Norlevo as an OTC medication represents a culmination of steps taken since 2016, when discussions began regarding the switch from prescription to over-the-counter availability. The move to grant OTC status was supported by extensive research and a pilot program initiated in 2023 aimed at ensuring that adequate conditions for the sale of emergency contraceptives are established, ensuring safety and accessibility for the public.

Daiichi Sankyo Healthcare Co., which will serve as the product's distributor, is committed to promoting proper sales and use of Norlevo, leveraging its experience with OTC products to ensure safe access for women. President Takahiro Uchida of Daiichi Sankyo Healthcare has expressed optimism about the product's potential in contributing to the enhancement of reproductive health awareness and practices in Japan.

Understanding Norlevo

Norlevo is recognized as Japan’s first approved emergency contraceptive, effectively acting as an “after pill” to prevent unintended pregnancies. The drug works by inhibiting ovulation and preventing fertilization and implantation within the uterus. To be most effective, Norlevo must be taken within 72 hours after unprotected intercourse, boasting an impressive pregnancy prevention rate of 81%. The World Health Organization designates Levonorgestrel as an essential medicine, reflecting its significant role in promoting women’s health worldwide.

Prior to this approval, Norlevo was only available as a prescription-only medication, which posed barriers for women needing prompt access to emergency contraception. With this switch, Aska Pharmaceutical aims to enhance the availability and accessibility of essential reproductive health services, helping to develop a more informed and healthier society. The medication will support women's autonomy in managing their reproductive rights and health decisions.

Future Outlook

As this monumental approval is expected to reshape the landscape of sexual and reproductive health in Japan, Aska Pharmaceutical plans to disseminate further details regarding the product specifications and release timeline soon. The company remains committed to addressing various health demands through innovative solutions, maintaining its position as a leading specialty pharmaceutical in the market.

Both Aska Pharmaceutical and Daiichi Sankyo Healthcare are eager to ensure that Norlevo is not only accessible but also used safely and effectively by women across Japan. Through targeted educational campaigns and information outreach, they aim to foster understanding about safe reproductive health practices, thus encouraging informed choices among consumers.

Aska Pharmaceutical stands firm in its mission to contribute to health and medical advancements that enhance societal well-being. As regulatory perspectives evolve and societal demands shift, Norlevo's approval marks a pivotal point in ensuring women's health remains a priority within Japan’s healthcare system.

While the journey towards full accessibility for emergency contraception in Japan has been long, the approval of Norlevo as an OTC product signifies a progressive step forward in improving public health services and responses to women's health needs.