Regulatory and Washington

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.

ATLANTA — Obesity rates continue to soar among the U.S. population, particularly in children. And the result, the Centers for Disease Control and Prevention reported, leads both to “psychosocial problems and to cardiovascular risk factors, such as hypertension, high cholesterol and abnormal glucose tolerance or diabetes.”

HYDERABAD, India — Indian drug maker Dr. Reddy’s Labs has launched a generic treatment for gastroesophageal reflux disease.

The company announced Thursday the launch of pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths. The drug is a version of Protonix, made by Wyeth, now part of Pfizer.

Pantoprazole sodium delayed-release tablets had sales of around $1.8 billion during the 12-month period ended in September 2010, according to IMS Health.

VALENCIA, Calif. — It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

The Food and Drug Administration on Thursday issued a complete response letter to the drug maker regarding Afrezza (insulin human [rDNA origin]) inhalation powder. The regulatory agency requested that the company conduct two clinical trials, one in patients with Type 1 diabetes and one in patients with Type 2 diabetes, with its next-generation inhaler, to assure it works as effectively as MedTone, its predecessor.

CAMBRIDGE, Mass. — The Food and Drug Administration and Health Canada have granted priority review to a drug for treating hepatitis C.

Vertex Pharmaceuticals announced Thursday that the two agencies had given the designation to telaprevir for treating patients with chronic infections.

WASHINGTON — Surgeon general Regina Benjamin on Thursday issued a “Call to Action to Support Breast-feeding,” outlining steps that can be taken to remove some of the obstacles faced by women who want to breast-feed their babies.

PITTSBURGH — The Food and Drug Administration has given tentative approval to an antiretroviral treatment for children with HIV and AIDS under the President’s Emergency Plan for AIDS Relief program.

Mylan announced Thursday that its subsidiary, Matrix Labs, had received the tentative approval for lamivudine and zidovudine tablets in the 30-mg/60-mg strength. The drug is a generic version of Combivir, made by ViiV Healthcare, a company specializing in HIV and AIDS created as a partnership between Pfizer and GlaxoSmithKline.

SOUTH SAN FRANCISCO, Calif. — Patients taking an investigational drug made by Genentech for advanced skin cancer fared better than those receiving standard treatments, according to results of a late-stage clinical trial announced Wednesday.

The company, part of Swiss drug maker Roche, said patients with advanced melanoma containing a mutated version of a protein called BRAF lived longer when receiving the orally administered personalized investigational medicine RG7204 than those receiving the injected chemotherapy drug dacarbazine.