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Kazano® ( alogliptin benzoate & metformin hydrochloride):TAKEDA PHARMACEUTICAL COMPANY LTD. et al v. INDOCO REMEDIES LTD.
Nesina®, Kazano®, and Oseni® (alogliptin benzoate; metformin hydrochloride ; pioglitazone hydrochloride ): TAKEDA PHARMACEUTICAL COMPANY LTD. et al TAKEDAnPHARMACEUTICALS U.S.A., INC.,TAKEDA PHARMACEUTICALS AMERICA, INC., and TAKEDA IRELANDnLIMITED,n v.v. TORRENT PHARMACEUTICALS LTD. and TORRENT PHARMA INC.,
The US Food and Drug Administration has dealt Merck & Co a blow in turning down its request to have cardiovascular outcomes data added to the labels of its diabetes drugs Januvia and Janumet.
Inisync combination tablets combine 25 mg alogliptin and 500 mg metformin, which is orally administered once daily. Nesina is a once-daily dipeptidyl peptidase-IV (DPP-4) inhibitor, and metformin is biguanide that inhibits sugar production in the liver administered twice or three times daily. Both of them are widely used as therapeutic drugs for the treatment of diabetes. Inisync is the only combination administered once daily of a DPP-4 inhibitor and metformin in Japan.
Takeda already knew from 2013 results of a cardiovascular outcomes trial that its Type 2 diabetes med, Nesina, didn’t increase the risk of CV events for ACS patients when compared with placebo. But now it knows the same is true of the risk of death.