Gaining an edge in the race to introduce a new class of DPP-4 inhibitors for type 2 diabetes, the FDA gave Merck a green light to start selling a pill that combines a generic metformin with its newly approved Januvia. The combo, called Janumet, gives Merck an added edge over Novartis, which has been making the case for Galvus in the U.S. and Europe. Janumet will quickly hit the market with the message that the combo offers a more convenient therapy for diabetic patients in need of multiple drugs.
- read the release on the approval
- here's the report on the decision from TheStreet.com
ALSO: Shares of Cephalon were on the rise in premarket trading this morning as analysts responded to the news that the FDA had issued another "approvable" letter for its sleep drug Nuvigil. The letter includes conditions that the company will have to meet before full approval is given. The FDA asked for additional data that had been collected and will require prominent safety warnings. Report
PLUS: The FDA approved Baxter International's Ceprotin, a drug designed to treat a rare blood disorder in newborns. Report