Posted 09 March 2012
By Alexander Gaffney
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 fumarate).
AstraZeneca said in a statement that it is "evaluating FDA's decision and reasoning."
FDA did not comment on AstraZeneca's argument in the Citizen Petitions, but said that its "decision to approve or not approve a specific application will be based on the particular facts that are applicable to that application at the time of the decision."
FDA further noted that the Abbreviated New Drug Applications (ANDAs) submitted to FDA may or may not use Seroquel or Seroquel XR as the Reference Listed Drug (RLD), adding that to accept AstraZeneca's petition would be to "short-circuit the application review process or to vitiate an ANDA or NDA applicant's procedural rights."
"Petitions are denied without comment on whether we will take the actions that you request," wrote FDA.
AstraZeneca - FDA responds to AstraZeneca Citizen Petitions on quetiapine product labelling
FDA - FDA/CDER to Covington & Burling LLP (AstraZeneca Pharmaceuticals LP) - Petition Denial
FDA - FDA/CDER to Covington & Burling LLP (AstraZeneca Pharmaceuticals LP) - Petition Denial (2)