PHARMACY

GSK, XenoPort receive complete response letter for RLS drug

BY Alaric DeArment

LONDON The Food and Drug Administration has declined to approve a drug used to treat restless leg syndrome, the drug’s makers announced Wednesday.

GlaxoSmithKline and XenoPort said they had received a complete response letter for the FDA for their application for Horizant (gabapentin enacarbil) extended-release tablets submitted in January 2009. A complete response letter means that the FDA has reviewed an approval application, but questions remain that preclude its approval.

The FDA cited a finding of tumors found in the pancreas cells of rats during preclinical testing as a sufficient concern to preclude the drug’s approval. While similar problems were found when the agency approved the drug as a treatment for refractory epilepsy, it said Horizant’s benefits for refractory epilepsy patients justified the potential risks. GSK and XenoPort have said they are evaluating the letter.

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Duane Reade opens fifth walk-in medical clinic in New York

BY Antoinette Alexander

NEW YORK A new walk-in clinic at a Duane Reade store in Chelsea officially opened on Wednesday, making it the fifth Duane Reade location with “Doctor on Premises” walk-in medical care.

The physician-staffed clinic is managed by Consumer Health Services and is also affiliated with Beth Israel Medical Center and St. Luke’s-Roosevelt Hospital Center. It is open Monday through Saturday, 10 a.m. to 6 p.m., and accepts most insurance plans.

“Walk-in, neighborhood-based medical care is a growing trend in this country, and it’s a very positive trend,” stated Dr. Maggie Bertisch, M.D., medical director for New York Walk-In Medical Group PC. “It allows healthcare providers to offer a more convenient, affordable alternative to crowded emergency rooms, while delivering safe, quality medical care in a New York minute.” According to CHS, Duane Reade is planning to add more on-site health clinics in 2010.

As reported, Walgreens, which owns retail-based clinic operator Take Care Health Systems, announced on Wednesday that is has reached an agreement to buy Duane Reade in a deal valued at nearly $1.1 billion.

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Hi-Tech Pharmacal, Mission Pharmacal to market new kidney stone treatment

BY Alaric DeArment

AMITYVILLE, N.Y. Hi-Tech Pharmacal and Mission Pharmacal Co. are planning to market a new treatment for kidney stones to doctors starting in April, the drug maker announced Wednesday.

Under a license agreement between the two companies, Hi-Tech will promote UroCit-K 15mEq (potassium citrate) extended-release tablets to primary care physicians through subsidiary ECR Pharmaceuticals, while Mission will promote it to urologists. The drug is a twice-daily treatment.

“We are pleased to introduce another unique prescription branded product to the primary care market,” Hi-Tech president and CEO David Seltzer said in a statement. “UroCit-K 15mEq is a highly effective product, available in a convenient dosing regimen which will increase patient compliance.”

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