PHARMACY

Study finds Pletal may prevent strokes

BY Alaric DeArment

NEW YORK A drug used to treat muscle pain resulting from exercise may be able to prevent strokes more effectively than aspirin, according to published reports.

According to a trial in Japan, the Cilostazol Stroke Prevention Study II, patients who had suffered ischemic stroke who took the drug cilostazol had a chance of recurrence 26% lower than patients who took aspirin.

Funding for the study came from Otsuka Pharmaceutical, the original manufacturer of cilostazol, under the brand name Pletal. The drug is also available in generic form.

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Report: Lawmakers seek to revise patent system

BY Alaric DeArment

NEW YORK Lawmakers in Washington have taken steps to reform the U.S. patent system, according to published reports.

Reuters reported Thursday that Senate Judiciary Committee chairman Sen. Patrick Leahy, D-Vt., and other members Congress had reached an agreement on patent reform, introducing a bill that would allow the patent office to set its own fees and allow judges decide the importance of an infringed patent as part of a product.

Drug companies, which depend on small numbers of patents, have opposed the effort, while large computer and hardware companies have supported it, Reuters reported.

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KV’s Ethex to plead guilty to criminal charges

BY Alaric DeArment

ST. LOUIS The generic drug marketing and distribution division of KV Pharmaceuticals will plead guilty to criminal charges and close shop under a deal between KV and the Department of Justice, KV announced Thursday.

The generic drug maker said Ethex will plead guilty to two felony counts and pay $27.6 million to resolve a criminal investigation of the company that began amid allegations that it failed to file field alerts to inform regulators of manufacturing problems with the drugs dextroamphetamine and propafenone in 2008. The payment includes a fine, $2.3 million in restitution to the federal government and an administrative forfeiture of $1.8 million.

“This settlement marks an important milestone in our efforts to restore normalized business operations at KV, regain full regulatory and legal compliance and set KV on a new path moving forward,” KV interim CEO David Van Vliet said in a statement. “Management and the board have been working diligently to address this issue, and we are looking forward to having this matter resolved.”

Ethex recalled a large number of generic drugs in late 2008 and early 2009 due to problems such as possibly oversized tablets and manufacturing deficiencies. In March 2009, the Food and Drug Administration filed an injunction against KV to prevent it from making or distributing adulterated and unapproved drugs and forced it to destroy all the drugs it had recalled, forbidding it from resuming manufacturing until the FDA was satisfied that it had been brought back into compliance with regulations. KV said the current settlement would allow it to continue manufacturing once it had regained compliance with the FDA’s current good manufacturing practices regulations, also known as cGMP.

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