Regulatory and Washington

ATLANTA — Nearly 26 million Americans have diabetes, according to new estimates from the Centers for Disease Control and Prevention released Wednesday.

In addition, an estimated 79 million U.S. adults have prediabetes, a condition in which blood sugar levels are higher than normal, but not high enough to be diagnosed as diabetes.

MORRISTOWN, N.J. — Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.

Watson, through subsidiary Watson Labs, said it applied for approval of a generic version of Daiichi Sankyo’s and Genzyme’s Welchol (colesevelam hydrochloride). The drug, a powdered oral suspension, is used to reduce “bad” LDL cholesterol in patients with primary hyperlipidemia, either alone or in combination with a statin.

PARIS — Sanofi-Aventis and its U.S. consumer healthcare division Chattem on Tuesday afternoon announced the Food and Drug Administration has approved the Allegra (fexofenadine HCl) family of allergy medication products for over-the-counter use in adults and children 2 years of age and older.

Products will be on store shelves in March, the companies announced.

JERUSALEM — Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

PITTSBURGH — Generic drug maker Mylan has entered settlements with Pfizer concerning two drugs for treating cholesterol.

Mylan announced Tuesday that it had settled patent litigation suits with Pfizer concerning Lipitor (atorvastatin calcium) and Caduet (atorvastatin calcium and amlodipine besylate).

Under the Caduet agreement, the lawsuit will be dismissed, and Mylan can launch its generic version on Nov. 30. Terms of the Lipitor agreement remain confidential.

ALEXANDRIA, Va. — Maneuvering to set forth a firm policy position in advance of President Barack Obama’s State of the Union address, the National Association of Chain Drug Stores again urged Congress Tuesday to “look to pharmacy as a solution in improving patient health and curbing healthcare costs.”

SAN DIEGO — The Food and Drug Administration has accepted a regulatory filing from Optimer Pharmaceuticals for a drug to treat bacterial infections.

Optimer announced Monday the FDA’s acceptance of its approval application for fidaxomicin for treating clostridium difficile infection, or CDI. CDI is a colon infection that is a particular problem in hospitals, long-term care centers and in the broader community. It is estimated to affect more than 700,000 people per year. The agency has granted the application priority review and expects to finish its review by May 30.

PHOENIX — In an effort to curb obesity rates in the United States, two lobbying groups announced a joint effort to fight the epidemic.

The Food Marketing Institute and Grocery Manufacturers Association said that Nutrition Keys, a voluntary front-of-pack nutrition labeling system, will help consumers make healthier choices when purchasing food. Front-of-pack nutrition labels place important nutrition information (i.e., calories, fat, saturated fat and sodium) where they can't be dismissed or ignored.