PHARMACY

FDA approves generic diabetes drug

BY Alaric DeArment

SILVER SPRING, Md. – The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

The FDA approved Macleods’ pioglitazone hydrochloride tablets in the 15 mg, 30 mg and 45 mg strengths.

The drug is a generic version of Takeda’s Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period that ended in August 2012, according to IMS Health.


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Elan sells Tysabri rights to Biogen Idec

BY Alaric DeArment

DUBLIN – Elan Corp. will sell the rights to its drug for multiple sclerosis to partnering company Biogen Idec for $3.25 billion plus royalties, the Irish drug maker said.

Elan said the sale of rights to Tysabri (natalizumab) to Biogen Idec would include royalties of 12% of global net sales of the drug and, after 12 months, a tiered royalty structure in which Elan would receive 18% on up to $2 billion of net global sales and 25% on sales of more than $2 billion. Meanwhile, Biogen Idec would have full ownership and control of the drug, and the current 50:50 collaboration between the two companies would be terminated.

"This transaction enables Elan and its shareholders to realize, upon close, a meaningful percentage of the current value of Tysabri while maintaining long-term cash flow realization through the multi-tiered royalty structure of the complete asset," Elan CEO Kelly Martin said. "The restructuring of this business collaboration provides Elan with significant strategic flexibility."


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Reports: Mass. health authorities shut down 10 compounding pharmacies over violations

BY Alaric DeArment

NEW YORK – Surprise inspections at 40 compounding pharmacies in Massachusetts last fall have led to 10 being ordered to stop sterile compounding, according to published reports.

State health authorities sent cease-and-desist letters to 11 pharmacies, telling 10 to stop compounding altogether and one to stop compounding the drug sildenafil citrate. Twenty-one other pharmacies were allowed to continue compounding, but were cited for minor violations.

The inspections followed a nationwide outbreak of fungal meningitis linked to an injectable steroid drug prepared at the New England Compounding Center in Framingham, Mass. As of Monday, the outbreak had led to 696 cases of meningitis and 45 deaths in 20 states.

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