Regulatory and Washington

DUBLIN — The Food and Drug Administration has approved a new drug from Warner Chilcott for treating ulcerative colitis, the drug maker said.

Warner Chilcott announced the approval of mesalamine in the 400-mg strength.

The company plans to market the drug under the brand name Delzicol and launch it in March.

ATLANTA — For the week ended Feb. 2, influenza activity remained elevated in the United States but decreased in most areas, the Centers for Disease Control and Prevention reported Friday. According to CDC's activity level map, it appears most incidence is concentrated across the central United States, including Texas, Oklahoma, Kansas and Missouri. 

 SILVER SPRING, Md. - The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

The FDA granted tentative approval to Dr. Reddy's Labs' valsartan tablets in the 40 mg, 80 mg, 160 mg and 320 mg strengths.

The drug is a generic version of Novartis' Diovan. Various versions of the drug had sales of $1.6 billion during the 12-month period that ended in June, according to IMS Health.

NEW YORK — Biotech drug maker Amgen plans to launch six biosimilar drugs starting in 2017, according to published reports.

NEW YORK — President Obama has re-nominated Marilyn Tavenner as administrator of the Centers for Medicare and Medicaid Services, according to published reports.

The Hill, a Washington-based newspaper that covers Capitol Hill, noted that Tavenner had received an endorsement from House majority leader Eric Cantor, R-Va., who had worked with her when she was in charge of the Medicaid program in his state. Still, she could face a tougher time in the Senate.

ALEXANDRIA, Va. — A survey of community pharmacists suggests that "preferred pharmacy" Medicare Part D drug benefit plans may pose challenges for seniors in rural communities. The finding comes shortly after similar questions were raised at the January public meeting of the Medicare Payment Advisory Commission, Congress' advisory board on Medicare issues, the National Community Pharmacists Association noted Thursday. 

NEW YORK — A new strain of the bacterium that causes whooping cough immune to vaccines may have appeared in the United States, according to a brief published Thursday in the New England Journal of Medicine.

The brief, filed by officials from the Centers for Disease Control and Prevention and other health authorities, reported that a strain of Bordetella pertussis had been reported in Japan, France and Finland and may have appeared in Philadelphia, where 12 children were hospitalized between 2011 and 2012.

ARLINGTON, Va. — National Association of Chain Drug Stores (NACDS) president and CEO Steve Anderson, calls a new study by the Centers for Medicare and Medicaid Services (CMS) “further proof of community pharmacy’s ability to improve patients’ lives while making healthcare more affordable in this country.”