FDA approves Barr extended-cycle oral contraceptive
MONTVALE, N.J. The Food and Drug Administration has approved a Barr Pharmaceuticals subsidiary’s application for a new oral contraceptive, Barr said Monday.
The FDA approved Duramed Pharmaceuticals’ drug LoSeasonique (levonorgestrel/ethinyl estradiol tablets and ethynyl estradiol tablets).
Barr said the drug is the first lower-dose, extended-cycle oral contraceptive. Under the extended-cycle regimen, women take combination tablets containing 0.1 mg of levonorgestrel and 0.02 mg of ethinyl estradiol for 84 consecutive days, followed by tablets containing 0.01 mg of ethinyl estradiol for seven days. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year.
“As a leader in women’s health, Duramed is committed to continuing to develop new products that provide women a choice as they discuss birth control options with their healthcare providers,” Duramed chief executive officer Fred Wilkinson said.
FDA launches new Web page to provide safety information on prescription drugs
WASHINGTON The Food and Drug Administration announced Wednesday that it had launched a Web page to provide consumers and healthcare professionals with a single source of safety information about prescription drugs.
The page, www.fda.gov/cder/drugsafety.htm, provides links to information in categories such as drug labeling, drugs with risk evaluation and mitigation strategies, regulations and guidance documents and warning letters, import alerts, recalls, market withdrawals and safety alerts.
“By placing Web links to these up-to-date resources on a single page, we’re helping consumers and healthcare professionals find drug safety information faster and easier,” said Dr. Paul Seligman, associate director of safety policy and communication in the FDA’s Center for Drug Evaluation and Research. “This type of communication is aimed at helping consumers and healthcare professionals make well-informed decisions about medication use.”
FDA approves generic version of Epivir
WASHINGTON The Food and Drug Administration has granted tentative approval to Indian drug maker Macleods Pharmaceuticals’ generic version of GlaxoSmithKline’s HIV drug Epivir (lamivudine), FDA records show.
The drug would be available as 150 mg and 300 mg tablets, but cannot be marketed in the United States because of patent protection.
GSK’s patent for lamivudine will expire in 2010. Epivir had sales of $246.85 million in 2007, according to GSK financial records.