PHARMACY

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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Lazanda approved as breakthrough pain treatment

BY Alaric DeArment

BEDMINSTER, N.J. — The Food and Drug Administration has approved a drug made by Archimedes Pharma for treating breakthrough pain in cancer patients, Archimedes said last week.

Archimedes announced the approval of Lazanda (fentanyl) nasal spray for cancer patients who have acquired a tolerance to opioid drugs. Breakthrough pain is an intense, sudden pain that is unpredictable and often debilitating and occurs despite otherwise appropriate pain therapy.

“Lazanda is an important new option for patients with cancer who experience excruciating breakthrough pain,” Archimedes Pharma CEO Jeffrey Buchalter said. “Lazanda, which uses our patented PecSys drug delivery system, is designed to deliver medicine in a rapid, but controlled manner, and provides patients with an effective alternative to manage their breakthrough pain.”

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