LONDON (MarketWatch) � The U.S. Food & Drug Administration has blocked AstraZeneca PLC�s attempt to delay the entry of generic versions of the U.K. drug maker�s anti-psychotic blockbuster Seroquel in the U.S. later this month.
AstraZeneca AZN �Friday said the FDA turned down its Citizen Petition requesting the U.S. regulator withhold final approval of any generic version of the medicine with labeling that didn�t have the same warnings that are required for its branded version.
AstraZeneca said it is reviewing the agency�s decision.
On Sept. 9, 2011, AstraZeneca filed separate Citizen Petitions with the FDA for Seroquel and Seroquel XR, requesting the agency withhold approval of any generic product of quetiapine--the active ingredient in Seroquel--that omits warnings about blood sugar levels and possible suicide, which the FDA required AstraZeneca to include in the labeling for its two branded versions.
The patent covering quetiapine expired in September 2011, with pediatric exclusivity set to expire on March 26.
Seroquel XR is covered by a formulation patent that expires in May 2017, with pediatric exclusivity expiring in November 2017. In 2011, AstraZeneca granted both Handa Pharmaceuticals and Accord Healthcare Inc. a license to enter the U.S. market with generic Seroquel XR on Nov. 1, 2016, or earlier under certain circumstances.
AstraZeneca shares were little moved by the news and at 0855 GMT were up 0.5% at 2,841 pence, but down 4.4% compared with a year earlier.
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