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Par subsidiary gets FDA nod for hypertension drug

BY Alaric DeArment

WOODCLIFF LAKE, N.J. — A subsidiary of Par Pharmaceutical Cos. acquired earlier this year has received its first Food and Drug Administration approval.

Par said Par Formulations received approval from the FDA for labetalol hydrochloride tablets in the 100-mg, 200-mg and 300-mg strengths. The drug, a generic version of Prometheus Labs’ Trandate, is used to treat hypertension.

Par acquired Par Formulations, formerly the Chennai, India-based drug maker Edict Pharmaceuticals, in February 2012.


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FDA appoints new generic drugs office head

BY Alaric DeArment

SILVER SPRING, Md. — The main office of the Food and Drug Administration in charge of regulating generic drugs has appointed a new director, the agency said Friday.

The FDA announced the appointment of Gregory Geba as director of the Office of Generic Drugs, replacing acting director Keith Webber, effective Sunday.

Geba has served in various senior-level clinical and managerial positions in the drug industry for the past 15 years, most recently as deputy chief medical officer for Sanofi US, a subsidiary of French drug maker Sanofi.


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Federal court rules in favor of Innovation Associates in 2006 patent-infringement case

BY Alaric DeArment

NEW YORK — A federal judge has ruled in favor of pharmacy technology manufacturer Innovation Associates in a 6-year-old case brought by ScriptPro concerning a component of one of Innovation’s dispensing robots, the companies said.

Mission, Kan.-based ScriptPro sued Johnson City, N.Y.-based Innovation in 2006, alleging that the output shelves on the latter’s PharmAssist Robotx automatic dispensing system infringed ScriptPro’s U.S. Patent No. 6,910,601, but U.S. District judge Carlos Murguia of the U.S. District Court for the District of Kansas ruled late last month that the patent was invalid.

"Innovation is delighted with judge Murguia’s ruling," Innovation CEO Mary Reno said. "It removes uncertainty in the marketplace and allows Innovation to sell its products to its customers without baseless threats of infringement."

ScriptPro said it would appeal the ruling to the Court of Appeals for the Federal Circuit, where it said the case would be reviewed de novo, meaning that the court would be allowed to re-examine the evidence and patent interpretation without being bound by the rulings and interpretations of the court at this level. ScriptPro further said that the U.S. Patent Office had reaffirmed that the ‘601 patent was valid. Meanwhile, Innovation said it also filed a counterclaim against ScriptPro, alleging that the latter "tortiously" interfered with Innovation’s customer relationships and saying that the case would be tried in the near future.

"We strongly believe that the ScriptPro patent that is the subject of the [Innovation Associates] case is a substantial invention, that all of the patent claims are valid and that the patent has been infringed by IA," ScriptPro president, CFO and CEO Mike Coughlin said. "And while the court proceeding will now be extended by appeal, we maintain our belief and expectation that we will ultimately prevail."


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