PHARMACY

FDA gives tentative approval to Dr. Reddy’s hypertension drug

BY Alaric DeArment

 SILVER SPRING, Md. – The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

The FDA granted tentative approval to Dr. Reddy’s Labs’ valsartan tablets in the 40 mg, 80 mg, 160 mg and 320 mg strengths.

The drug is a generic version of Novartis’ Diovan. Various versions of the drug had sales of $1.6 billion during the 12-month period that ended in June, according to IMS Health.

Tentative approval means that a drug meets the FDA’s conditions for approval, but the agency can’t give it final approval due to patent or exclusivity issues. 

In early January 2013, the U.S. District Court for the District of Columbia upheld an FDA decision protecting Ranbaxy Labs’ market exclusivity for its generic valsartan tablets.


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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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