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news.The US Food and Drug Administration (FDA) has accepted for standard review of Merck's new drug application (NDA) of investigational extended-release formulation of Janumet as a treatment for type 2 diabetes.
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Merck said that the extended release formulation of Janumet is composed with sitagliptin, Januvia’s (sitagliptin) active component and metformin extended release, which is a treatment for type 2 diabetes.
Janumet is contraindicated in patients with renal disease, renal dysfunction, or abnormal creatinine clearance; and acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma; or history of a serious hypersensitivity reaction to Janumet or sitagliptin, such as anaphylaxis or angioedema.
Merck Research Laboratories Clinical Research vice president Barry Goldstein said the filing of the extended-release formulation of Janumet demonstrates Merck’s commitment to providing novel treatment options to people with type 2 diabetes who need them.
"With the approval of the extended-release formulation of Janumet, Merck would have the only DPP-4 inhibitor in combination with both immediate-release metformin and extended-release metformin, giving healthcare providers more options to treat their patients with type 2 diabetes," Goldstein said.