AstraZeneca today announced that the European Commission (EC) has issued a positive decision for the approval of once-daily SEROQUEL XR (quetiapine fumarate) Extended Release Tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy. This decision follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) in April of this year.
AstraZeneca will now move forward in obtaining local approvals. This is a 30 day process in the 17 member states that took part in the original Mutual Recognition Procedure. For other member states timelines will vary.
Within this application, the product information for SEROQUEL XR has been updated with respect to several individual safety topics such as: suicidality, weight gain, hyperglycaemia, extrapyramidal symptoms, akathisia, somnolence, orthostatic hypotension, and dizziness. Guidance is also provided on safe administration of SEROQUEL XR, including consideration of the safety profile with respect to the individual patient’s diagnosis and the dose being administered. Implementation of this updated product information will occur upon obtaining local approval. (Source: Astrazeneca press release)
Showing posts with label Seroquel xr. Show all posts
Showing posts with label Seroquel xr. Show all posts
Tuesday, September 7, 2010
Friday, August 27, 2010
Torrent gets another bad news and this time its by manufacturing partner:AstraZeneca
The UK-based drug major AstraZeneca has filed one more patent lawsuit against Gujarat-based Torrent Pharmaceuticals and its US subsidiary, for alleged move to manufacture and sell the generic version of its extended release anti-psychotic drug, Seroquel XR prior to the expiry of its patent.
AstraZenca, a UK based drug major company which has just entered as manufacturing partnership with Torrent pharma in March 2010.
AstraZeneca has filed a complaint against Torrent Pharma in the District Court of New Jersey, US, following the a Para IV filing to produce and market the quetiapine fumarate extended release drug, the generic form of AstraZeneca's Seroquel XR, used to treat schizophrenia and bipolar disorder, which is having sales value of $913 million.
Full article can be view at http://www.pharmabiz.com/article/detnews.asp?articleid=57084§ionid=
AstraZenca, a UK based drug major company which has just entered as manufacturing partnership with Torrent pharma in March 2010.
AstraZeneca has filed a complaint against Torrent Pharma in the District Court of New Jersey, US, following the a Para IV filing to produce and market the quetiapine fumarate extended release drug, the generic form of AstraZeneca's Seroquel XR, used to treat schizophrenia and bipolar disorder, which is having sales value of $913 million.
Full article can be view at http://www.pharmabiz.com/article/detnews.asp?articleid=57084§ionid=
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