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Takeda gets Japan's nod for multiple sclerosis injection

29 September 2015 | Regulatory | By BioSpectrum Bureau

Takeda gets Japan's nod for multiple sclerosis injection

Takeda Pharmaceutical has a obtained new drug application approval for Copaxone Subcutaneous Injection

Takeda Pharmaceutical has a obtained new drug application approval for Copaxone Subcutaneous Injection

Singapore: Japan based Takeda Pharmaceutical has a obtained new drug application approval for Copaxone Subcutaneous Injection 20 mg Syringe (generic name: glatiramer acetate), for the treatment of multiple sclerosis, from the Japanese Ministry of Health, Labour and Welfare.

Developed by Teva Pharmaceutical, Copaxone is a subcutaneous injection administered once daily to prevent the relapse of multiple sclerosis.

In Japan, glatiramer acetate was developed as an unapproved new drug by Teva Pharmaceutical, a wholly owned subsidiary of Teva, at the request of the Japanese Ministry of Health, Labour and Welfare. In March, 2013, Takeda and Teva signed a licensing agreement in which Teva granted Takeda the right to commercialize glatiramer acetate in Japan.

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