Merck reports financial results, regulatory updates

Merck & Co. Inc. (NYSE:MRK) reported financial results on Thursday and provided a regulatory update, including announcing FDA approval of an extended-release, once-daily formulation of Janumet sitagliptin/metformin to treat Type II diabetes. Merck plans to launch the product "in the next several weeks." Merck already markets an immediate-release, twice-daily formulation of Janumet, which is a fixed-dose combination of Merck's Januvia sitagliptin and metformin.

Merck also said FDA issued a complete response letter for an sNDA for Dulera mometasone/formoterol to treat chronic obstructive pulmonary disease (COPD). The pharma said it is discussing the letter with FDA, but did not disclose details. Dulera is approved in the U.S. for asthma. ...