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Impax settles with Genzyme over kidney dialysis drugs

BY Alaric DeArment

HAYWARD, Calif. — Generic drug maker Impax Labs has settled with a subsidiary of Sanofi regarding generic versions of two drugs for dialysis patients, Impax said Tuesday.

Impax announced a settlement with Genzyme concerning generic versions of Renvela (sevelamer carbonate) 800 mg tablets and 2.4 g and 0.8 g oral suspension and Renagel (sevelamer hydrochloride) tablets in the 400 mg and 800 mg strengths.

Under the settlement, Impax will have a license to sell its generic versions of the drugs on Sept. 16, 2014, or possibly earlier. Impax said it was likely the first company to file a complete regulatory approval application with the Food and Drug Administration for versions of both drugs, which are used to control serum phosphorus in patients with chronic kidney disease on dialysis. If it is, then it would be entitled to 180 days of market exclusivity in which to compete directly with the branded versions upon receiving FDA approval.

Renagel and Renvela had sales of $512 million between April 1, 2011 and the end of 2011 and $392 million in the first half of 2012, according to Sanofi.


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Kroger highlights achievements in sustainability report

BY Allison Cerra

CINCINNATI — Kroger has released its sixth annual sustainability report.

"Kroger associates embrace sustainability in their everyday business practices," Kroger chairman and CEO David Dillon said. "In 2011, our stores saved enough energy to power every single-family home in Columbus, Ohio, for a single year. We’re proud to have donated the equivalent of 160 million meals to local food banks through our partnership with Feeding America, placing us among the top-tier donors. We continue our commitment to help make the world a better place in a variety of ways."

Some highlights of Kroger’s environmental and social sustainability progress in 2011:

  • Kroger has saved more than 2.34 billion kilowatt hours of electricity, which equals 1.47 million metric tons of greenhouse gas emissions. That equates to taking more than 292,000 cars off roads for one year;

  • In 2011, the company’s Ralphs/Food 4 Less Division designed and built a unique resource recovery system, which is expected to convert 55,000 tons of unsold organics, annually, into renewable energy that will power its own facility;

  • Improved bagging techniques and increased use of reusable bags have prevented approximately 1 billion plastic bags from being used since 2008. In 2011, Kroger sold and provided customers with more than 5.3 million reusable bags, an average of 14,200 per day; and

  • Together, Kroger vendors and customers raised more than $5.5 million in support of women’s health and breast cancer awareness programs.

To read the full report, click here.

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FDA approves Wockhardt antidepressant

BY Alaric DeArment

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic antidepressant made by Wockhardt, the Indian drug maker said Tuesday.

Wockhardt announced the FDA approval of its bupropion hydrochloride extended-release tablets in the 100 mg, 150 mg and 200 mg strengths.

The drug is a generic version of GlaxoSmithKline’s Wellbutrin SR, various versions of which have a market of about $268 million, according to IMS Health.


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