PHARMACY

Par to restructure branded business

BY Allison Cerra

WOODCLIFF LAKE, N.J. — As part of a strategic assessment, generic drug maker Par Pharmaceutical is set to restructure its branded division.

The company said last week that its restructuring of Strativa Pharmaceuticals will result in a reduced workforce, prompting one-time noncash charges in the second quarter in addition to severance costs, although Par said the restructuring will generate expense savings in the $8 to $12 million range for the remainder of the year.

"To achieve our goal of optimizing Strativa’s potential, we found it necessary to reduce the number of sales representatives and focus on Megace ES and Nascobal at this time," Par chairman, president and CEO Patrick LePore said. "We remain fully committed to the branded business and believe it is a valuable platform for future growth."

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Xarelto OKed by FDA

BY Alaric DeArment

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said Friday.

Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.

“The approval of once-daily Xarelto tablets will provide a new option to help protect patients from developing venous blood clots following knee or hip replacement surgery,” Harbor-UCLA Medical Center professor of orthopedic surgery Louis Kwong said on behalf of J&J. “Xarelto has a proven clinical benefit over one of today’s most widely used options in preventing these potentially life-threatening blood clots, and the use of a once-daily pill may play an essential role in helping to simplify clinical practice.”

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Novartis receives FDA approval for COPD drug

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Novartis for treating chronic obstructive pulmonary disease, the FDA said Friday.

The FDA approved Arcapta Neohaler (indacaterol inhalation powder) for long-term, once-daily maintenance of bronchodilator treatment of airflow obstruction in people with COPD, including chronic bronchitis and emphysema.

COPD, which often results from cigarette smoking, is the fourth-leading cause of death in the United States, according to the Centers for Disease Control and Prevention.

Arcapta Neohaler is marketed by Novartis Pharmaceuticals Corp., an East Hanover, N.J.-based subsidiary of the Swiss drug maker.

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