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FDA approves Sagent’s Granisetron

BY Alaric DeArment

SCHAUMBURG, Ill. The Food and Drug Administration has approved a generic injectable drug made by Sagent Pharmaceuticals and used for sickness related to chemotherapy, Sagent announced Wednesday.

The FDA approved granisetron hydrochloride, for preventing nausea and vomiting caused by chemotherapy, in the 0.1 mg per milliliter, 1 mg per milliliter and 4 mg per milliliter strengths. The company plans to begin marketing the drug in third quarter 2010.

Granisetron had sales of $26 million in 2009, according to IMS Health, and is a generic version of Roche’s Kytril, which the FDA approved in 1993.

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Save Mart to use MirixaEdge in employee health-and-wellness initiative

BY Allison Cerra

RESTON, Va. A regional supermarket chain with 244 stores in California and Nevada has selected Mirixa’s Web-based clinical application for the delivery of medication therapy management services as an integral part of its employee health-and-wellness initiative.

Save Mart said MirixaEdge — which will be deployed to Save Mart Supermarkets’ 115 in-store pharmacies by May — will encourage employees to play an active role in their medication therapy management and develop patient medication records with the help of vital information providing by the application. In addition to medication therapy management, MirixaEdge includes patient care program templates for such chronic conditions as asthma, diabetes and cardiovascular disease. These templates help to guide the pharmacist through the data collection process for illnesses that typically involve multiple medications and coexisting conditions, Save Mart said.

“Our company believes that our employees are a vital company asset and their well-being is of paramount importance,” said Michele Snider, executive director pharmacy at Save Mart. “We want to empower our employees and actively engage them in the management of their health and wellness. MirixaEdge will enable our pharmacists to consult directly with employees and to help them to understand why they are prescribed specific medications and why they should take the medications as prescribed.”

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Novartis says MS drug reduces relapse in patients

BY Alaric DeArment

BASEL, Switzerland An investigational drug made by Novartis for multiple sclerosis reduced annual relapse rates in new patients by 62% compared with placebo, according to data from a two-year, late-stage clinical trial the Swiss drug maker showed Tuesday at a scientific meeting.

Presenting results from the phase 3 FREEDOMS trial at the annual meeting of the American Academy of Neurology, Novartis said the once-daily pill Gilenia (fingolimod) administered in 0.5 mg doses also reduced relapses by 44% in patients who had previously taken other treatments while delaying the progression of disability by 30%.

“These findings reinforce the potential for Gilenia to be a breakthrough therapy option for physicians and people with relapsing forms of MS,” Novartis Pharma global head of development Trevor Mundel said.

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