This approval is based on the application that Kyowa Kirin had filed in January 2022 for manufacturing and marketing approval
Kyowa Kirin has announced that its product mitomycin C agent (MITOMYCIN 2mg for Ophthalmic Topical Use), licensed from Intas Pharmaceuticals, (Intas) was approved by the Ministry of Health, Labour and Welfare (MHLW) for “an adjunct to open glaucoma surgery” in Japan.
The Japanese Ophthalmological Society has requested that the anticancer agents, mitomycin C, which are marketed by Kyowa Kirin in Japan, can be used during surgery for glaucoma with ocular hypertension.
Additionally, MHLW reported its opinion that mitomycin C meets the “criteria for medical necessity” at the "Review Committee on Unapproved or Off-label Drugs with High Medical Need" back in May 2019. Kyowa Kirin later received a request for development for this indication from MHLW.
This approval is based on the application that Kyowa Kirin had filed in January 2022 for manufacturing and marketing approval of mitomycin C agent, as a topical ophthalmic agent which is licensed from Intas for the Japanese market.
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