AstraZeneca Sues FDA to Halt Generic Seroquel

| 14 March 2012 | By Alexander Gaffney, RAC

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 decision that it would not comment on AstraZeneca's claims except to say it's "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."

In its lawsuit, AstraZeneca referenced its arguments made in the Citizen Petitions, particularly "regarding labeling requirements for generic copies of innovative medicines, as well as data exclusivity rights granted to innovative companies that conduct new clinical trials."

Generic copies of Seroquel are scheduled for release in late March unless AstraZeneca's injunction is granted.

Read more:

Reuters - AstraZeneca sues FDA over generic Seroquel

Pharma Times - AZ sues FDA in generic Seroquel dispute