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Report: Mylan temporarily banned from launching generic acne drug

BY Alaric DeArment

NEW YORK — Mylan will be banned temporarily from launching a generic drug for acne pending a federal court’s decision whether or not to bar it, according to published reports.

According to Bloomberg, the U.S. District Court for the District of Delaware ruled that Mylan violated 1-of-4 patents covering the acne drug Oracea (doxycycline), sold by Galderma Labs. Galderma, New York University and the Research Foundation of the State University of New York sued Mylan for patent infringement related to the drug in 2009. The court will wait to decide whether to bar Mylan from launching.

Patents covering Oracea are scheduled to expire between Aug. 30, 2016, and Dec. 19, 2027, according to Food and Drug Administration records.

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FDA accepts application for opioid-induced constipation drug

BY Alaric DeArment

TARRYTOWN, N.Y. — The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

The two drug makers announced Tuesday that the FDA had accepted their supplemental new drug application for Relistor (methylnaltrexone bromide), an injectable drug for treating opioid-induced constipation.

The drug originally was approved for treating patients taking opioids for cancer pain, but the companies are seeking approval for OIC in patients with pain not related to cancer. The FDA plans to make a decision on the drug by April 27, 2012.

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Kroger hasn’t forgotten; grocer to commemorate 9/11 in stores through September

BY Michael Johnsen

CINCINNATI — Kroger on Tuesday reported the company will coordinate a moment of silence across all 2,449 stores in its network on Sept. 11 to remember the victims and honor the heroes of the 9/11 tragedy.

"To commemorate the 10th anniversary of the 9/11 attacks, we will invite our customers and associates to join together in a moment of silent reflection in all of our supermarkets," stated Dave Dillon, chairman and CEO of Kroger. "We also heard from many associates that they wanted to recognize the heroes in their communities during this time of national remembrance. Many of our stores will also say ‘thank you’ to our everyday heroes — the men and women who keep our families, communities and stores safe — through a variety of activities this September."

For example, across some districts, Kroger is making arrangements to prepare and deliver lunches, food trays, sheet cakes or gift baskets to local first responders, including fire departments, police departments and paramedics. In other districts, customers will be able to write personal messages on oversized cards or posters displayed in stores thanking military and emergency services personnel for their service.

Kroger also will encourage associate donations to the USO, a nonprofit, congressionally chartered, private organization whose mission is to help boost morale across the U.S. Armed Forces.

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