FDA to review Duramed’s Lo Seasonique extended-cycle contraceptive
MONTVALE, N.J. Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, has received notification from the Food and Drug Administration that the agency has accepted for review it drug application for Lo Seasonique, an extended-cycle oral contraceptive.
The drug, which has the ingredients of levonorgestrel 0.10mg/ 0.02 mg of ethinyl estradiol would be taken for 84 days, followed by seven days of 0.01 mg of ethinyl estradiol. This regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year.
The data supporting the drug application came from a large multi-centered, open label clinical trial, which concluded in June 2007. The trial involved over 2,200 women between the ages of 18 and 40 over a period of 12 months.
If approved, the drug would be the first lower dose, extended-cycle oral contraceptive. The FDA’s expected action is Oct. 24.
Von Eschenbach, Leavitt visit Dr. Reddy’s facility in India
HYDERABAD, India In January 2008 Food and Drug Administration Commissioner Andrew von Eschenbach and Secretary of Health and Human Services Michael Leavitt visited a Dr. Reddy’s facility near the pharmaceutical manufacturer’s headquarters here.
Leavitt was focused on assuring the quality of the products as well as creating collaborations beyond borders while von Eschenbach, also concerned with the safety and quality of products, focused on the transparency of the manufacturing process.
Dr. Reddy’s was the only facility in India the two visited as part of a multi-national effort to ensure the safety of the pharmaceutical supply chain.
Congressional report estimates CMS changes would cost states $50 billion in federal aid
WASHINGTON According to a congressional report prepared by the Democratic staff on the House Committee on Oversight and Government Reform, proposed changes to Medicaid would cost states about $50 billion in federal aid over the next five years, the Associated Press reported.
“As the economy tips into recession, the last thing we should be doing is taking federal funds from states, especially funds that are supposed to help people with their health and medical expenses,” said committee chairman, Rep. Henry Waxman, D-Calif.
Federal officials, though, are arguing that the changes are designed to ensure that providers don’t bill the program for more than costs of providing care and also say that the states pay their fare share of the program.
Tthe proposed new rules include limiting Medicaid public hostpital reimbursement to no more than the cost of providing a particular service. Another would prohibit billing Medicaid for the costs of medical interns and residents.
Overall, the federal government will spend more than $1.2 trillion on Medicaid over the next five years. The administration projects that if all the changes it seeks were enacted, the federal government would save about $13 billion over those five years.