subject: Finally You Can Order Generic Seroquel! [print this page] FDA Approved on it in Spite of AstraZeneca Complaints
AstraZeneca in March 2012 revealed its intention to make near $2 billion from sales of its antipsychotic Seroquel as prescription for children of the age under 17 years old. This fact is quite shocking, because the drug itself is quite a strong medication, and it is distressful to find out that so many children really need it.
But the reason behind it can turn out even more astonishing: The Food and Drug Administration gave permission to produce several generic analogues of the drug.
For that AZ cried out that they were going to lose at least $2.1 billion in prospect Seroquel volume of sales only this year, unless the FDA was forbidden to authorize cheaper versions, such as Pharmalot.
When the FDA did not incline to their protests, AZ brought out a claim against the agency.
This is how large pharma companies act when facing a threat of appearing a new generic version in the market, such as generic Seroquel pills.
Other alleged tactic is making pay-to-delay deals with generics manufacturers, which is scourged by the Federal Trade Commission. In this case brand label producers pay their generics counterparts to stop patent charges.
And if a company attempted to sue a federal agency, this means they are desperate and have no hope to extend their patents neither for the brand name, not for tweaks to their product, such as generic Seroquel pills.
Today you are allowed to order generic Seroquel from a famous generics producer Teva.
In the beginning of March 2012 AstraZeneca tried to defend that, according to the U.S. Supreme Court's decision of 2011 in case Pliva v. Mensing, it's doubtless that generic versions must bear the same labeling as the originals. But a part of Seroquel labeling, according to AZ, was founded on scientific tests, on which AZ bears exclusive rights for the whole year 2012. This means that the FDA approval for generic Seroquel was illegal, argued AZ, because the generics' labeling would appear in violation of AZ's exclusive rights.
However, the Food and Drug Administration told District Judge of federal court in Washington, D.C., Colleen Kollar-Kotelly that the lawsuit was ungrounded, because the administration hadn't yet authorized on the generic. And 4 days later, astonishingly, the FDA allowed manufacturing of the generics, thus leaving AZ without their $3.3 billion-a-year medicine. Generic Seroquel pills are widely sold and available in a variety of dosages.
