PHARMACY

Watson sues Barr alleging patent infringement regarding Oxytrol

BY Alaric DeArment

CORONA , Calif. Watson Pharmaceuticals announced Friday that it had filed a lawsuit against Barr Pharmaceuticals and subsidiary Barr Laboratories in the United States District Court of Delaware, alleging patent infringement.

The suit concerns an application that Barr filed with the Food and Drug Administration, requesting approval to market a generic version of Watson’s drug Oxytrol (oxybutynin transdermal system). Barr said the patents covering Oxytrol were invalid and unenforceable.

Watson filed the lawsuit under the Hatch-Waxman Act, which allows for the manufacture and marketing of generic drugs. Under the act, the FDA cannot approve Barr’s application unless a district court judge rules in favor of the company or two and a half years from Watson?s receipt of Barr?s notice letter.

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FDA launches new Web page to provide safety information on prescription drugs

BY Alaric DeArment

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.”

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FDA approves generic version of Epivir

BY Alaric DeArment

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.

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