Court clears way for generic Crestor.
WASHINGTON -- A federal judge has refused to issue a temporary restraining order blocking approval of new generic versions of AstraZeneca's blockbuster cholesterol drug Crestor in the United States. U.S. District Judge Randolph Moss ruled that AstraZeneca was unlikely to win a lawsuit claiming that it should receive seven more years of exclusive rights to the drug due to its recent approval to treat a rare pediatric illness.
Generic drug makers, including-Sandoz, Apotex and Mylan, said in court filings that they would launch generic versions of Crestor, which lost patent protection on July 8.
AstraZeneca said in a statement that it was disappointed with the decision. Its strategy to extend exclusivity had encountered sharp criticism from federal legislators, who appealed in a letter to the Food and Drug Administration not to let the company exploit a "loophole. "
Allergan PLC, which has been selling generic Crestor in the U.S. since May under a licensing agreement with AstraZeneca, was not affected by the court's order.
Crestor, which accounted for over 20% of AstraZeneca's $23.6 billion in sales last year, was approved by the FDA in 2003 for the treatment of high cholesterol. In May of this year, the agency approved the addition of a new indication for use to the drug's label for the treatment of homozygous familial hypercholesterolemia in patients 7 to 17 years old. The rare genetic disease, which causes high cholesterol and sometimes heart disease, affects about one in a million people.
In June, AstraZeneca won seven years of exclusive marketing rights for the new indication under the orphan drug program. AstraZeneca subsequently sued the FDA, seeking to block final approval of any new generic Crestor. The company claimed that federal law required drugs to include all pediatric indications on their labels.
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|Title Annotation:||Supplier News|
|Publication:||Chain Drug Review|
|Date:||Aug 8, 2016|
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