Astra's injunction against the FDA denied by US court

A US court has dismissed AstraZeneca's lawsuit against the Food and Drug Administration (FDA) which sought to delay the marketing approval of genetic copies of a quetiapine drug.

SEROQUEL and SEROQUEL XR tablets, also known as 'quetiapine fumarate', are an antispsychotic drug used in the treatment of schizophrenia, bipolar disorder and depression.

After the FDA denied Astra's petition regarding labelling requirements for generic copies of the drugs earlier in the month, the pharmaceuticals giant decided to seek an injunction barring the FDA from releasing them onto the market.

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It was announced this morning that the US District Court for the District of Columbia has denied the firm's request for a preliminary injunction and dismissed the lawsuit without prejudice.

"Notwithstanding the court's decision, the company continues to believe strongly in the merits of its position and is evaluating its options," the company said in a statement.

BC