State, territorial attorneys general call for anti-tampering measures in opioids
NEW YORK — The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.
In a letter to FDA commissioner Margaret Hamburg, the attorneys general, writing on behalf of the National Association of Attorneys General, wrote that people who abuse opioid painkillers are increasingly using those that lack tamper-resistant features. While Purdue Pharma’s OxyContin (oxycodone) has tamper-resistant features, some, such as North Carolina attorney general Roy Cooper, expressed concerns that future generic versions of the drug – which loses patient protection this year – may not have tamper-resistant features unless the FDA requires them.
"As a specific example, we are concerned with the possibility that generic versions of extended-release opioid prescription drugs and other non-tamper-resistant products may reach the market," the attorneys general wrote. "We applaud the FDA for expeditiously proposing guidelines establishing clear standards for manufacturers who develop and market tamper- and abuse-resistant opioid products while considering incentives for undertaking the research and development necessary to bring such products to market."
The attorneys general included those of Puerto Rico, Guam and every state except Indiana, Virginia, Connecticut and Michigan.
Actavis seeks approval for Alzheimer’s patch
PARSIPPANY, N.J. — Actavis is challenging Novartis’ patent on a patch used to treat Alzheimer’s disease, Actavis said.
The generic drug maker said it had filed with the Food and Drug Administration an amendment to its regulatory application for rivastigmine transdermal system to include the 13.3 mg-per-24-hours dosage strength, a generic version of Novartis’ Exelon. Novartis filed suit against Actavis on Thursday in the U.S. District Court for the District of Delaware seeking to prevent commercialization of the generic version.
In November 2011, the company, then known as Watson Pharmaceuticals, filed an application with the FDA for a generic version of Exelon in the 4.6 mg-per-24-hours and 9.5 mg-per-24-hours strengths. Novartis sued to prevent commercialization of those strengths separately.
Actavis said it was likely the first company to file applications for generic versions of Exelon, which would entitle it to 180 days of market exclusivity in which to compete directly against the branded version. Exelon had sales of about $521 million during the 12-month period that ended in January, according to IMS Health.
Teva CFO to present at Barclays conference
JERUSALEM — Teva Pharmaceutical Industries will sponsor a live audio webcast at the 2013 Barclays Global Healthcare Conference on Thursday, the Israeli generic drug maker said Tuesday.
Teva CFO Eyal Desheh will present. The company is one of several scheduled to present at the conference this week.
The webcast will be available on the company’s website and is scheduled to begin at 9:30 Eastern time. An archive of the webcast will be available afterward.