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FDA advisory committee to meet in July on opioid painkiller

BY Alaric DeArment

SYDNEY — A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug’s developer said Friday.

Australia-based QRxPharma said the FDA had determined that an advisory committee would meet on July 17 to consider a resubmitted application for Moxduo, an immediate-release formulation of the opioid painkillers morphine and oxycodone.

The company has sought approval for the drug since summer 2011, and the FDA has indicated it will decide whether or not to approve it in August 2013. The agency is not required to follow advisory committee recommendations in deciding whether or not to approve a drug, but usually does.

 

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New vitamin-based anti-aging serum hits market

BY Antoinette Alexander

BOISE, Idaho — Epionce has announced the launch of Intense Defense Anti-Aging + Repair Serum, which it is positioning as the first complete multivitamin for the skin.

The serum is designed to stimulate skin rejuvenation using botanical sources of vitamins A, B, C, D and E without irritation.

In an independent clinical study, Epionce Intense Defense Serum was tested against Skin Medica TNS Recovery Complex serum and Skinceuticals CE Ferulic serum. The Intense Defense Serum was proven to diminish signs of visible aging faster than the other two serums, and with far better tolerability, according to the manufacturer.
 

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Mylan launches cholesterol drug

BY Alaric DeArment

PITTSBURGH — Mylan has launched a generic drug for treating cholesterol, the company said Friday.

Mylan announced the launch of fenofibrate tablets in the 48 mg and 145 mg strengths. The drug is used to reduce so-called "bad" low-density lipoprotein cholesterol, total cholesterol, triglycerides and apolipoprotein B while increasing "good" high-density lipoprotein cholesterol in adults with primary hyperocholesterolemia or mixed dyslipidemia.

The drug is a generic version of AbbVie’s Tricor. Various versions of the drug had sales of about $1.2 billion during the 12-month period that ended in March 2013, according to IMS Health.


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