PHARMACY

Report: Kinney Drugs’ new specialty Rx subsidiary to open mail-order facility in DeWitt

BY Antoinette Alexander

GOUVERNEUR, N.Y. — Specialty pharmacy service provider Noble Health Associates, a newly created subsidiary of regional player Kinney Drugs, is looking to open a mail-order facility in DeWitt, N.Y., according to a local news report.

Director of specialty pharmacy for Noble Health Michael Becker told The Post-Standard that it plans to open the facility in the spring or summer and will employ 31 people.

Noble Health will dispense, by mail, specialty medications for diseases such as AIDS, according to the article. The business in DeWitt will process orders, package the medications and ship them, serving customers throughout the country, The Post-Standard reported.
 

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FDA approves Uceris for ulcerative colitis

BY Alaric DeArment

SAN DIEGO — The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.

Santarus announced the approval of Uceris (budesonide) extended-release tablets for mild to active UC. The company plans to launch the drug in March.

"We are pleased to provide a new option for patients to treat the active phase of mild to moderate ulcerative colitis," Santarus president and CEO Gerald Proehl said. "With the incremental revenue from Uceris and continued growth in our marketed products, we anticipate another robust year of solid financial results for Santarus in 2013."

Proehl said the company expected the drug to have sales of $320 million to $325 million.


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FDA sets generic drug user fee rates for 2013

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Wednesday.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.

The fees for domestic factories making final dosage forms and active pharmaceutical ingredients are $175,389 and $26,458, respectively. For foreign factories, the fees are respectively $190,389 and $41,458.

The agency said that under the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, the fee for a factory outside the United States should be $15,000 to $30,000 higher than the fee for a domestic factory.

The FDA said it calculated the fee using data submitted by generic drug facilities through the self-identification process mandated under GDUFA.


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