PHARMACY

Teva announces inhaler with dose counter for bronchospasm

BY Alaric DeArment

NORTH WALES, Pa. — An inhaler for patients with bronchospasm that includes a dose counter has become available from Teva Respiratory, the company said Thursday.

The company, which is the branded respiratory division of Israeli drug maker Teva Pharmaceutical Industries, announced the available of ProAir HFA (i.e., albuterol sulfate), for patients aged 4 and older to prevent and treat bronchospasm with reversible obstructive airway disease and prevent exercise-induced bronchospasm. The inhaler received Food and Drug Administration approval in March 2012.

"As the market leader in quick-relief inhalers, we are pleased to offer patients the latest in product enhancements designed to help better manage their condition," Teva Global Respiratory Research and Development SVP Tushar Shah said. "This milestone in the ProAir brand shows our continued efforts to deliver the best treatment solutions that meet patients’ or their caregivers’ needs."


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PHARMACY

FDA approves Watson heavy menstrual bleeding drug

BY Alaric DeArment

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for heavy menstrual bleeding made by Watson Pharmaceuticals, the drug maker said Thursday.

Watson announced the approval of tranexamic acid tablets through a subsidiary and plans to ship it immediately. The drug is a generic version of Ferring Pharmaceuticals’ Lysteda.

Ferring has filed suit against Watson, alleging that the generic drug infringes two of its patents. Lysteda had sales of about $25 million during the 12-month period that ended in November, according to IMS Health.


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Ranbaxy preserves exclusivity period for generic hypertension drug

BY Alaric DeArment

WASHINGTON — A court has ruled in favor of Indian generic drug maker Ranbaxy Labs in a case concerning a generic blood pressure drug, the legal firm representing the drug maker said.

Zuckerman Spaeder LLP said the U.S. District Court for the District of Columbia upheld a Food and Drug Administration decision protecting Ranbaxy’s market exclusivity for a generic version of Novartis’ drug Diovan (valsartan).

Ranbaxy asserted that as the first company to successfully challenge one of the patents covering Diovan, it was entitled to 180 days of market exclusivity in which to compete directly with the branded version, under the Hatch-Waxman Act of 1984, but another company had sought to challenge the exclusivity.


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