• AstraZeneca Sues FDA to Halt Generic Seroquel

    Pharmaceutical manufacturer AstraZeneca filed a lawsuit on 13 March seeking an injunction against the US Food and Drug Administration (FDA) to bar it from allowing generic versions of its blockbuster antipsychotic drug Seroquel to be marketed in the US. FDA denied two Citizen Petitions from AstraZeneca on 9 March that requested FDA delay market entry for any generic products not containing the exact warnings contained on the reference listed drug (RLD). FDA said in its...
  • Petitions to Delay Generic Seroquel Denied

    Two petitions from pharmaceutical manufacturer AstraZeneca that could have delayed market competition to its flagship line of antipsychotic drugs were denied by the US Food and Drug Administration (FDA) on 9 March. AstraZeneca's Citizen Petitions requested that FDA delay market entry for generic products if those products omitted warnings about the risk of developing hyperglycemia. FDA required AstraZeneca to include such warnings on Seroquel and Seroquel XR (quetiapine ...