Content about Merck & Co.

BOSTON — Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

Merck expects to file a new drug application to the Food and Drug Administration in 2012. If approved, suvorexant would be the first medicine approved in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep. Merck anticipates that suvorexant will be evaluated by the Controlled Substance Staff of the FDA.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

Merck said the agency issued a complete response letter for its regulatory approval application for a drug that would combine the cholesterol drug Zetia (ezetimibe) with atorvastatin, the active ingredient in Pfizer's Lipitor. A complete response letter means that the FDA cannot approve a drug application in its current form.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug that it called the first single-pill combination treatment for Type 2 diabetes and high cholesterol.

The FDA approved Merck's Juvisync (sitagliptin and simvastatin), manufactured by Merck subsidiary MSD International GmbH Clonmel Co., based in Tipperary, Ireland. Merck operates under the name MSD outside the United States and Canada in order to avoid confusion with Germany-based Merck KGaA.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted a regulatory approval application from Merck and Ariad Pharmaceuticals for a new drug to treat soft-tissue and bone cancers, the drug makers said Wednesday.

The FDA is expected to complete its review of ridaforolimus for soft-tissue and bone sarcomas in patients who have shown a favorable response to chemotherapy by second quarter 2012.

Sarcomas are cancers of the body's connective tissues, and treatment options remain limited, the companies said.

NEW YORK — Attacks on a human papillomavirus vaccine made amid an increasingly caustic Republican presidential primary battle have drawn a response from the manufacturer.

SILVER SPRING, Md. — The Food and Drug Administration has approved changes to the labels of several drugs made by Merck, the agency said Friday.

Merck’s Label Standardization Project includes the revision of 34 container labels for 16 drugs, all orally administered pills. These include the cardiovascular drugs Cozaar (losartan) and Hyzaar (losartan and hydrochlorothiazide), the diabetes drugs Januvia (sitagliptin) and Janumet (sitagliptin and metformin), the allergy and asthma drug Singulair (montelukast), the HIV drug Isentress (raltegravir) and others.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted an approval application from Merck for a drug to treat eye diseases, Merck said Wednesday.

Merck is seeking approval for Saflutan (tafluprost) ophthalmic solution, an investigational drug for relieving eye pressure in patients with glaucoma and ocular hypertension.

BLOOMFIELD, Conn. An insurance company and a patient assistance program have joined forces to improve medication adherence outcomes of Type 2 diabetes patients.

PHILADELPHIA Drug advertisements that tie disease risks with family history can influence consumers' choice of medications and have a beneficial effect on those consumers' lifestyle choices, according to a study published in the August issue of the Journal of Applied Communication Research.