Regulatory and Washington

MENLO PARK, Calif. — Optivia Biotechnology on Tuesday announced that the company and the Food and Drug Administration have signed a collaboration agreement to assess the effect of dietary supplements on key drug transporters.

Drug transporters are proteins on the surface of cells that either facilitate or hinder the transport of nutrients or pharmaceuticals. Drug transporters can increase or decrease the absorption of drugs into the body, as well as limit or facilitate the exposure of certain organs.

WASHINGTON — Addressing the obesity epidemic in the United States, the Department of Agriculture and Department of Health and Human Services unveiled the 2010 Dietary Guidelines for Americans.

DGA can help Americans maximize the nutritional content of their meals by providing advice for making food choices that promote good health, a healthy weight and prevent disease for healthy Americans ages 2 years and older, the USDA and HHS said. Key recommendations include:

• Balancing calories to maintain a healthy weight;

ATLANTA — The Centers for Disease Control and Prevention on Friday updated the nation’s influenza status. Nine states are reporting high influenza-like activity (a metric that captures the severity of a flu outbreak) and 25 states are reporting widespread activity (a metric that captures the estimated level of spread of influenza activity through state and territorial epidemiologists reports.)

POINT RICHMOND, Calif. — Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

Transcept resubmitted its new drug application for Intermezzo (zolpidem tartrate) on Jan. 18 after receiving a complete response letter from the FDA in October 2009. The drug maker said for the completion of the NDA review, the FDA set the PDUFA action date for July 14.

ALEXANDRIA, Va. — Concerns that contracting rules affecting healthcare providers that service Tricare beneficiaries could extend to retail pharmacies has prompted the country’s largest chain pharmacy lobby to file a friend-of-the-court brief in a lawsuit over the regulations.

The National Association of Chain Drug Stores filed an amicus curiae brief in support of the defendant in the case, Office of Federal Contract Compliance Programs, U.S. Department of Labor v. Florida Hospital of Orlando.

PITTSBURGH — The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.

Mylan announced the approval Friday of nisoldipine extended-release tablets in the 8.5-mg, 17-mg, 25.5-mg and 34-mg strengths. The drug is a generic version of Shionogi Pharma’s Sular, which had sales of about $103 million during the 12-month period ended in September 2010, according to IMS Health.

SILVER SPRING, Md. — The safety of silicone breast implants has long been a subject of controversy, but a review by the Food and Drug Administration indicated another possible health risk.

The FDA said Thursday that it had found a possible association between saline and silicone gel-filled breast implants and a rare cancer called anaplastic large-cell lymphoma, and that patients with implants may have a “very small but significant” risk of ALCL in the scar capsule adjacent to the implant.

CUPERTINO, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a pain drug that it previously had declined to approve.

Durect announced Thursday that the FDA had accepted a resubmitted application by King Pharmaceuticals for Remoxy (oxycodone), a controlled-release painkiller designed to reduce the risks of misuse. King and Pain Therapeutics are developing the drug using Durect’s drug-delivery technology.