Survey

This month we would like to know...

With the recent introduction of 2 new protease inhibitors as adjunctive therapies for the management of hepatitis C, what do you envision your organization's approach will be to managing the use of these products?

a) Selection of 1 preferred product only

b) Maintain both agents on formulary and allow providers to choose

c) Employ prior authorization to validate clinical appropriateness before coverage

d) a & c

e) b & c

Digital Edition

FDA panel recommends withdrawing Avastin indication for breast cancer treatment

An FDA advisory panel recommended in late June that Avastin should not be used to treat breast cancer. Read full article.

FDA approves tamper-resistant pain drug, Oxecta

FDA granted approval to Pfizer and Acura Pharmaceuticals for a new formulation of oxycodone hydrochloride (HCl) (Oxecta USP Tablets CII) that is designed to be tamper resistant, according to a joint statement from the 2 companies. Read full article.

Amgen submits application to expand indication for Xgeva

Amgen has submitted a supplemental Biologics License Application (sBLA) to FDA to expand the indication for Xgeva (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases, according to a company press release. Xgeva currently is approved in the United States for the prevention of skeletal-related events in patients with bone metastases from solid tumors. Read full article.

FDA approves only once-daily LABA for COPD

FDA has approved once-daily indacaterol inhalation powder (Arcapta Neohaler, Novartis) 75 µg for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Arcapta is not indicated for acute deteriorations of COPD or to treat asthma. Read full article.

FDA approves Xarelto to help prevent DVT in patients undergoing knee- or hip-replacement surgery

FDA has approved rivaroxaban tablets (Xarelto, Janssen Pharmaceuticals), a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT), which may lead to a pulmonary embolism (PE) in people undergoing knee- or hip-replacement surgery. Xarelto is the only new oral anticoagulant with FDA approval for this indication. Read full article.

FDA approves first fentanyl nasal spray for the management of breakthrough cancer pain

FDA has approved the first and only fentanyl nasal spray (Lazanda, Archimedes) in the United States for the management of breakthrough pain in cancer patients aged 18 years and older who are already receiving opioid therapy to which they are tolerant, for their underlying persistent cancer pain. Read full article.

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