Friday, July 13, 2012

Bye bye Seroquel, hello quetiapine

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.

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