Pharmaceutical Business review

FDA accepts Merck Janumet extended release formulation NDA for review

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.