Just Approved & Launched

• Purdue Pharma L.P. released the middle-of-the-night prescription sleep aid Intermezzo® (zolpidem tartrate) sublingual tablet CIV in 1.75 mg and 3.5 mg dosage strengths to pharmacies nationwide in April. Intermezzo® should only be taken once per night in bed, as needed, when a patient with insomnia wakes up in the middle of the night and has difficulty returning to sleep, and is not indicated for use when a patient has fewer than four hours of bedtime remaining before the planned time of waking, according to Purdue Pharma. Intermezzo®, which was approved by the U.S. Food and Drug Administration in November 2011, is available in spearmint-flavored sublingual tablets that are placed under the tongue and allowed to disintegrate completely before swallowing.

• Pharmaxis Ltd. received Marketing Authorization for the cystic fibrosis treatment Bronchitol from the European Commission in April. Bronchitol will be made available to patients 18 years old and older in 29 European countries. In two large Phase 3 clinical trials, Bronchitol improved mucus clearance, improved lung function, and reduced infectious episodes when patients were treated for six months, according to Sydney-based Pharmaxis. Bronchitol is approved for marketing in Australia and has been recommended for listing on Australia’s Pharmaceutical Benefits Scheme.

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