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Takeda and Andrx diabetes drug submitted for US approval

Takeda has filed a new drug application with the FDA seekings approval for a treatment for type 2 diabetes that combines the company's already approved drug Actos with Andrx Corporation's extended-release metformin.

This new drug application (NDA) filing triggers the payment to Andrx of the third $10 million development milestone in the collaboration between the two companies.

“We are extremely satisfied to see several years of development work come to fruition with the filing of an NDA for a product jointly developed by Andrx and Takeda. This once-a-day combination product is designed to provide a more convenient treatment option for those affected by type 2 diabetes,” said Thomas Rice, Andrx CEO.

Andrx and Takeda Pharmaceutical entered into the collaboration to jointly develop the combination product in January 2004.

Under the agreement, Andrx will manufacture this combination product, if and when it is approved, and Takeda will hold exclusive, worldwide marketing rights.