Drugs giant AstraZeneca has filed a lawsuit against US regulators to overturn last week's denial of petitions with regard to generic versions of its SEROQUEL and SEROQUEL XR tablets.
The tablets, also know as 'quetiapine fumarate', are an antispsychotic drug used in the treatment of schizophrenia, bipolar disorder and depression.
On March 7th, Astra filed a 'citizens petition' to raise issues regarding labelling requirements for generic copies of "innovative medicines" as well as data exclusivity rights. This was denied by the Food and Drug Administration (FDA).
MoneyWeek
Subscribe to MoneyWeek today and get your first six magazine issues absolutely FREE
Sign up to Money Morning
Don't miss the latest investment and personal finances news, market analysis, plus money-saving tips with our free twice-daily newsletter
Don't miss the latest investment and personal finances news, market analysis, plus money-saving tips with our free twice-daily newsletter
The company is attempting to delay the realise onto the market of the generics.
"AstraZeneca seeks an injunction barring the FDA from granting final marketing approval of generic quetiapine until December 2nd 2012 when regulatory exclusivity expires on important clinical trial data, or, alternatively, at least until a federal court has a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications," the firm said on Tuesday morning.
"AstraZeneca will vigorously defend its legal rights."
BC
-
MoneyWeek news quiz: How much could you get in car finance compensation?The car finance scandal, inheritance tax, and house prices all made headlines over the past few days. Test your knowledge while reviewing this week’s top stories with MoneyWeek’s news quiz
-
The biggest fossil fuel financing banks – is yours on the list?You may not know it, but your savings could be being used to finance the fossil fuel industry. We look at the banks with the best and worst climate policies.
