PHARMACY

Purdue pays out over $7 million over OxyContin

BY Drew Buono

ALBANY, N.Y. Purdue Pharma has paid New York State over $7 million in damages in connection to misrepresentations about the dangers of the drug OxyContin.

Sales managers were taught that OxyContin produced less euphoria in users and had less potential for abuse than short acting opioid medications.  Prosecutors allege that Purdue’s research contradicted these claims.

“This is a dangerous, deadly drug with a well-documented history of causing addiction in its users,” Attorney General Andrew Cuomo said. “Nevertheless, Purdue actively promoted OxyContin as a safe and less-addictive alternative to other painkillers.”

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Evista gets FDA approval for new use to reduce breast cancer risk

BY Drew Buono

INDIANAPOLIS The Food and Drug Administration has approved a new application for Eli Lilly’s osteoporosis drug Evista. The drug is now indicated as a way to reduce the risk of invasive breast cancer.

The drug’s new use is designed for postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer. “The FDA’s decision marks a major milestone. For the first time, postmenopausal women with osteoporosis will have one treatment option that can help address two leading health concerns—osteoporosis and invasive breast cancer,” said Gwen Krivi, vice president of Lilly Research Laboratories.

The approval comes less than a year after the application was submitted to the FDA and also carries a recommendation of the Oncologics Drug Advisory Committee.

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Cubist to ask for patent reissue for Cubicin

BY Drew Buono

LEXINGTON, Mass. Cubist Pharmaceuticals is planning on asking U.S. regulators to reissue a patent on the drug Cubicin to block generic competition.

Cubicin is used as a treatment for skin infections and is set to lose its patent in 2016.  Cubist is going to ask the U.S. Patent and Trademark Office to correct and reissue a patent regarding the purity level of the compound daptomycin, which is the key ingredient in Cubicin.

On Wednesday, generic manufacturers were allowed to seek approval from the Food and Drug Administration to sell generic versions of the drug.  Now, with Cubist seeing corrections from the patent office, the original patent will be removed from the FDA’s registry of information on approved drugs until the mater is handled.

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