Takeda Resubmits Diabetes Drug for FDA Approval
The drug manufacturer hopes the FDA will approve alogliptin as a stand-alone treatment and as a single-pill therapy in combination with pioglitazone, a previously approved drug.
Takeda Pharmaceutical Company has resubmitted two new drug applications to the FDA for a type 2 diabetes medicine.
The drug manufacturer hopes that the FDA will approve alogliptin as a stand-alone treatment and as a single-pill therapy in combination with pioglitazone, a previously approved drug. The FDA will review the resubmissions within the next six months.
Alogliptin, designed to regulate blood glucose levels, was discovered by Takeda San Diego and rejected in June 2009 by the FDA, which said the company needed to conduct more tests.
The company has conducted 12 phase III clinical trials of alogliptin involving 8,000 patients worldwide.
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