AstraZeneca’s Seroquel gets closer to a green light in US

11 April 2012

Pharmaceuticals giant AstraZeneca today received a boost when the US drug watchdog took the first steps to approve its $4.5 billion anti-psychotic medicine Seroquel for use by children.

Mayfair-headquartered AstraZeneca, the UK's second-largest drug firm, had asked the US Food and Drug Administration to approve Seroquel as a treatment for children and teenagers suffering from schizophrenia and bipolar mania in October.

For today's decision advisors to the FDA said that the drug appears "safe" and "effective" for children, and the watchdog is now expected to clear them for paediatric use. Pfizer's Geodon and Eli Lilly's Zyprexa were also given the board's backing.

The market for anti-psychotic drugs is growing, especially in the US where sales topped $14 billion last year. For AstraZeneca, Seroquel is the second-best selling drug in its portfolio, but its reputation was hit last month when leaked emails, revealed as part of a law suit, suggested the pharma firm was trying to push Seroquel for uses that were not approved by safety regulators.

The drug giant is being sued by 16,000 American patients for "spinning, skewing and concealing" information on the medicine's potential side-effects.

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