Regulatory and Washington

HYDERABAD, India — A federal court has lifted an injunction that had prevented drug maker Dr. Reddy’s Labs from marketing a generic version of an allergy drug.

Dr. Reddy’s said the U.S. District Court of New Jersey had filed a stipulation and order lifting the earlier injunction against the drug maker regarding the selling of a version of fexofenadine hydrochloride and pseudoephedrine hydrochloride tablets in the 180-mg/240-mg strength. The drug is a generic version of Sanofi-Aventis’ and Albany Molecular Research’s Allegra-D 24.

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.

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;

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.

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.

LONDON — The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

GSK said the FDA issued a complete response letter for its application seeking approval for Avodart (dutasteride) to reduce the risk of prostate cancer in men at increased risk of developing the disease. The drug already is approved to treat enlarged prostate.

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.