AstraZeneca Loses Fight Over Generic Seroquel

     (CN) – A federal judge shot down the latest attempt by AstraZeneca Pharmaceuticals to block Food and Drug Administration approval of the generic versions of its antipsychotic drug Seroquel.
     The drug is considered atypical because it results in fewer undesirable side effects such as tics and tremors, compared to previous antipsychotics. Schizophrenia and bipolar disorder are among the conditions the drug is used to treat.
     Regulators gave the green light to the generic forms of Seroquel on March 27, 2012, just four days after U.S. District Judge Colleen Kollar-Kotelly dismissed AstraZeneca’s previous legal effort to enjoin its generic competition.
     AstraZeneca sued the FDA again on March 28, this time arguing that it has total market exclusivity over certain safety information accompanying the drug until early December.
     U.S. District Judge Beryl Howell granted the FDA’s motion for summary judgment with a sealed opinion issued on June 28. Howell issued an amended memorandum opinion on Thursday.
     AstraZeneca will keep its exclusivity for certain pediatric uses of Seroquel until Dec. 2 because of the additional medical studies it conducted concerning those uses.
     But Howell also found that the FDA reasonably withheld exclusivity over the safety labeling from AstraZeneca.
     The judge admonished the FDA for not being more “forthcoming” concerning its stance prior to the second lawsuit.
     “By waiting until March 27, 2012 to explain its reasoning for not recognizing exclusivity for Seroquel labeling, the FDA needlessly delayed consideration of the merits of the agency’s determination, which could have been considered when AstraZeneca filed its first complaint for injunctive relief and caused the plaintiff and this court to participate in a fire drill to resolve these significant legal issues in the context of a temporary restraining order on March 28, 2012,” according to a footnote in the 49-page order.

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