Regulatory and Washington

EAST HANOVER, N.J. The Food and Drug Administration has approved a single-pill combination of two drugs made by Novartis for treating high blood pressure, the Swiss drug maker said Friday.

The FDA approved Tekamlo (aliskiren and amlodipine besylate) tablets, which combine Tekturna (aliskiren) with amlodipine, a channel blocker available as a generic. The drug is approved for treating patients who are likely to need multiple drugs to lower their blood pressure or as a replacement for patients who can’t control it using one of the drugs alone.

SWIFTWATER, Pa. The Food and Drug Administration has accepted an application from Sanofi Pasteur to expand the use of a vaccine in children.

Sanofi Pasteur, the vaccines division of French drug maker Sanofi-Aventis, announced Thursday the FDA’s acceptance of its application seeking approval of Menactra (meningococcal [groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine) for active immunizations of infants and toddlers against invasive meningococcal disease.

ALEXANDRIA, Va. Reps. Mike Rogers, R-Mich.; Zack Space, D-Ohio; Lee Terry, R-Neb.; and Peter Welch, D-Vt., have sent a letter to the Centers for Medicare and Medicaid Services recommending CMS keep prices for its national competitive bidding program for Medicare Part B mail-order diabetes testing supplies separate from similar supplies offered by retail pharmacies, the National Community Pharmacists Association announced Thursday.

ALEXANDRIA, Va., and ST. PAUL, Minn. A White House report encouraging the healthcare system’s transformation to health information technology drew a strong endorsement Tuesday from the nation’s largest electronic prescription network.

SILVER SPRING, Md. —The Personal Care Products Council announced in July that it is working to create formal processes for the Food and Drug Administration to review ingredients of personal care products for safety at the request of the public and stakeholder groups, and to review all safety determinations made by the Cosmetic Ingredient Review expert panel.

SILVER SPRING, Md. The Food and Drug Administration has approved the first generic version of a Sanofi-Aventis injected drug used to treat deep vein thrombosis, the agency said Friday.

The FDA approved generic enoxaparin sodium, a version of Sanofi’s Lovenox, developed under a collaboration between Momenta Pharmaceuticals and Sandoz, the generics division of Swiss drug maker Novartis.

WASHINGTON While there is a need to modernize the regulatory structure of the cosmetics industry, the newly proposed Safe Cosmetics Act of 2010 as written "is not based on credible and established scientific principles" and would place an "enormous, if not impossible, burden on the Food and Drug Administration," the Personal Care Products Council stated in response to the legislation introduced on Wednesday.

WASHINGTON A reported excess of a quarter billion dollars is a good case for increasing use of generic drugs under the Medicaid program, according to the main lobby for the generic drug industry.

Responding to a report by conservative think tank the American Enterprise Institute that identified $271 million in wasteful Medicaid spending, the Generic Pharmaceutical Association said it was a “compelling case” for increasing generic drug utilization.