FDA approves Elite Pharmaceuticals’ opioid painkiller
NORTHVALE, N.J. — The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.
Elite announced the FDA approval of its supplemental application for the manufacture and packaging of naltrexone hydrochloride tablets in the 50-mg strength. The company said the approval would allow it to start manufacturing and packaging the drug for its sales and marketing partner, Mikah Pharma, from which it bought rights to the drug in September 2010.
The drug is a generic version of Duramed’s Revia. The branded drug and generic versions had sales of about $16 million in 2012, according to IMS Health.
McKesson, Safecor Health partnership generating cost savings, efficiencies for alternate site pharmacies
SAN FRANCISCO — Alternate site pharmacies, including those serving long-term care and correctional care facilities, are realizing significant cost savings and greater efficiencies as a result of an innovative partnership forged by McKesson and Safecor Health, the San Francisco wholesaler announced Monday. According to McKesson, the year-over-year benefit can be as high as 15.5%.
"Alternate site pharmacies manage a great deal of complexity and associated cost in serving their customers, including operational inefficiencies, regulatory mandates, safety concerns and more," stated Rich McKeon, VP McKesson Alternate Site Pharmacy. "The McKesson/Safecor Health Partnership helps to alleviate the cost and complexity burden; it addresses evolving packaging needs based on the pharmacy’s business model, without upfront capital investments or extra staff."
The McKesson/Safecor Health Partnership combines McKesson’s distribution services with Safecor Health’s FDA-registered drug repackaging and barcoding services to deliver customized medication packaging solutions with low pricing to alternate site pharmacies.
The McKesson/Safecor Health Partnership also addresses medication packaging needs for alternate site pharmacies preparing to implement CMS-mandated changes for short-cycle dispensing, which became effective Jan. 1.
McKesson and Safecor Health estimated that a long-term care pharmacy serving 2,000 beds can realize a more than $57,000 annual cost benefit — a 15.5% improvement year over year — as a result of implementing the McKesson/Safecor Health third-party repackaging solution.
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Report documents opportunities, challenges for biosimilars
NEW YORK — A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.
The report, by auditing and finance firm Grant Thornton, argues that regulatory challenges, clinical trials and efficacy tests continue to present a “huge investment outlay.” Over the next four years, the report found, branded biologics representing $40 billion in sales will come off patent, not to mention the $20 billion worth of products already off patent.
The Generic Pharmaceutical Association, a trade group representing generic drug makers, said the report “underscores the need for swift and decisive action to make the promise of biosimilar medicines a reality for the millions of American patients in need of lifesaving biologic treatments.”
“Even with the most conservative estimates, this report shows that biosimilars hold the potential to save $20 billion annually,” GPhA president and CEO Ralph Neas said, calling for state legislatures to defeat what he called efforts by biotech drug makers Amgen and Genentech to limit future access to biosimilars.
A regulatory approval pathway for biosimilars was mandated in the Patient Protection and Affordable Care Act, and the Food and Drug Administration is currently in the process of developing regulations governing them.