US pharmaceutical company Par Health Inc announced on Friday the launch of its generic version of Merck's Janumet XR (sitagliptin and metformin HCl extended-release) tablets for oral use, following final approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application.
Par Health's sitagliptin metformin XR is the first and currently the only FDA-approved generic of Janumet XR available in the United States. According to IQVIA data, Janumet XR had estimated annual US sales of approximately USD269.9m for the 12 months ended May 2026.
Janumet XR is a registered trademark of Merck Sharp & Dohme LLC.
AcuCort secures renewed FDA fee waiver ahead of planned NDA submission
Yarrow Bioscience completes VYNE merger and begins Phase 2 trial of YB-101
Asymchem's DH2 site completes first FDA inspection for continuous manufacturing of API
Par Health launches generic version of Janumet XR tablets in US
FDA approves Furoscix ReadyFlow for at-home treatment of edema
FDA grants Fast Track designation to Lundbeck's narcolepsy candidate Lu AH69593