Regulatory and Washington

WASHINGTON — The Medicare Fraud Strike Force on Thursday charged 111 defendants in nine cities — including doctors, nurses and healthcare company owners and executives — for their alleged participation in Medicare fraud schemes involving more than $225 million in false billing. The operation marks the largest federal healthcare-fraud takedown.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for a rare bleeding disorder.

The FDA announced the approval of Corifact, used to prevent bleeding in people with the genetic disorder congenital Factor XIII deficiency, which affects 1-in-3 million to 5 million people in the United States.

The drug is manufactured by Marburg, Germany-based CSL Behring.

NASHVILLE, Tenn. — Tennessee makes the third state this year, joining Kentucky and Nevada, that is considering state legislation to mandate the sale of pseudoephedrine as prescription-only. That could prove a big concern for the legitimate market for PSE products on account of the potential snowball effect such legislation could have on neighboring states. According to a government review staff in Kentucky, at least 97.8% of all PSE sales are bought for legitimate use.

Generic drug usage already has been on the rise year after year, with no sign of slowing down. As Jody Fisher, VP marketing for healthcare analytics at market research firm SDI, has told Drug Store News, generics accounted for more than 70% of products dispensed at retail pharmacies and are set to increase further this year.


HAYWARD, Calif. — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

The drug maker on Friday said it received final approval of its abbreviated new drug application for doxycyline monohydrate capsules in the 150-mg strength. The drug, which is a tetracycline antibiotic used to treat bacterial infections, is a generic version of Adoxa. Adoxa is manufactured by PharmDerm, a Nycomed subsidiary.

Impax said its generic division, Global Pharmaceuticals, will launch the product.

SILVER SPRING, Md. — An asthma drug widely available as a generic should not be used for preventing or treating preterm labor in pregnant women, the Food and Drug Administration warned.

NORTH WALES, Pa. — Generic drug maker Teva Pharmaceutical Industries has launched a generic drug for treating symptoms of menopause.

Teva announced Thursday the availability of Jinteli (norethindrone acetate and ethinyl estradiol) tablets.

The drug is a generic version of Warner Chilcott’s FemHRT and is available in the 1-mg/5-mcg strength.

WASHINGTON — February is American Heart Month, and a professional group representing the country’s pharmacists is using that as an opportunity to encourage the public to learn how to prevent heart disease from the most easily accessible members of the healthcare system.