PHARMACY

Mylan’s generic arthritis drug receives FDA approval

BY Alaric DeArment

PITTSBURGH The Food and Drug Administration has approved a generic arthritis treatment made by Mylan, the drug maker said Wednesday.

 

The FDA approved nabumetone tablets, a treatment for osteoarthritis and rheumatoid arthritis, in the 500 mg and 750-mg strengths.

 

 

Nabumetone tablets had sales of $68 million during the 12-month period ended in March, according to IMS Health. SmithKline Beecham, a predecessor company to GlaxoSmithKline, originally sold nabumetone tablets under the brand name Relafen, though Relafen no longer is available.

 

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Watson seeks FDA approval for generic Renvela, confirms patent challenge

BY Alaric DeArment

MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals hopes to be the first to market a version of a kidney disease treatment made by Genzyme, Watson said Monday.

Watson said it filed a regulatory approval application with the Food and Drug Administration for sevelamer carbonate for oral suspension. The drug is a generic version of Genzyme’s Renvela, used to control serum phosphorus in patients with chronic kidney disease who are on dialysis.

 

Watson’s application included a Paragraph IV certification, a legal assertion that the patents covering Renvela are invalid, unenforceable or won’t be infringed by a generic version, prompting Genzyme to file a patent infringement suit in the U.S. District Court for the District of Maryland. Watson’s case puts a stay of final FDA approval of Watson’s product for two and a half years or until the two companies resolve the matter before the court.

 

 

In May, Watson also filed for approval of a generic version of Renvela in tablet form.

 

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NEVHC utilizing new robotic medication dispensing system

BY Alaric DeArment

JOHNSON CITY, N.Y. A network of health centers in California is using Innovation’s robotic medication dispensing system, Innovation said Tuesday.

The Northeast Valley Health Corp., in San Fernando, Calif., is using Innovation’s PharmAssist ROBOTx dispensing system to fill prescriptions at its 12 health centers, including its mobile van, throughout California’s San Fernando and San Clarita valleys.

“Prior to implementing PharmAssist ROBOTx, we were struggling to keep up with the prescription volume across all our health centers, which was putting a lot of stress on our staff,” NEVHC director of pharmacy Rosie Jadidian said. “Since going live earlier this year, we are now able to complete our daily workload, which averages 650 prescriptions but goes as high as 1,200 prescriptions on some days.”

Jadidian said the system, which now fills around 50% of NEVHC’s prescriptions, has made it possible for the company to make plans to open a new health center without hiring a pharmacist.

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