PHARMACY

FDA finds no evidence of vast quality-control errors at Mylan manufacturing plant

BY Alaric DeArment

PITTSBURGH A Food and Drug Administration inspection of a plant owned by generic drug maker Mylan has turned up no evidence of widespread manufacturing violations reported Sunday in the Pittsburgh Post-Gazette, Mylan announced Tuesday.

The Post-Gazette published an investigative report Sunday alleging that workers at Mylan’s plant in Morgantown, W.Va., had ignored and deleted computerized warnings of problems with drugs and the equipment used to manufacture them, based on leaked internal documents.

The company contacted the FDA, prompting the agency to visit the Morgantown plant. Mylan said the FDA found a “minor” deviation in standard operating procedures, but that the company had corrected the problem.

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Taro files patent infringement suit against three companies

BY Alaric DeArment

HAWTHORNE, N.Y. An Israeli generic drug maker has sued three other companies, alleging patent infringement.

Taro Pharmaceutical Industries announced Monday that it had filed suit in the U.S. District Court for the District of New Jersey against Synerx Pharma, DPT Labs and Karalex Pharma, alleging infringement of U.S. Patent No. 7,560,445. The patent covers Taro’s Ovide (malathion) lotion in the 0.5% strength, a treatment for head lice.

Taro said the defendants’ generic versions of the drug infringed its patent, and it’s seeking injunctive relief and damages.

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News article calls Mylan’s quality control into question; company responds

BY Alaric DeArment

PITTSBURGH A news article published over the weekend calling generic drug maker Mylan’s manufacturing into question has drawn a response from the company.

The Pittsburgh Post-Gazette reported Sunday that workers at the company’s Morgantown, W.Va., plant overrode drug quality controls required by the government by ignoring and deleting computer warnings of possible drug quality or equipment problems, based on a confidential internal report obtained by the newspaper’s reporters that called it a “pervasive” problem. Normally the warnings, known as “red screens,” require production to halt until a quality-control agent can investigate the matter.

The company responded by saying in a statement Monday that the Post-Gazette article was based on anonymous sources, improperly obtained documents and third-party commentary.

“Our customers and stakeholders can rest assured that whenever there is even the slightest departure from [a standard operating procedure], it will be dealt with immediately and effectively,” the company said in a statement. “This issue had no impact on the quality of our product.”

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